Fat tissue treatment

ABSTRACT

A system for treating fat tissue, including:
         an ultrasound applicator, including:   two or more ultrasound transducers configured to generate and direct ultrasonic waves to a selected tissue volume including fat tissue;   a control unit, including:   a control circuitry electrically connected to the two or more ultrasound transducers, wherein the control circuitry is configured to activate the two or more ultrasound transducers to heat the selected tissue volume.

RELATED APPLICATION/S

This application claims the benefit of priority under 35 USC § 119(e) ofU.S. Provisional Patent Application No. 62/713,578 filed 2 Aug. 2018,the contents of which are incorporated herein by reference in theirentirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to fattissue treatment, for example a cosmetic fat tissue treatment and, moreparticularly, but not exclusively, to fat tissue treatment usingultrasonic energy.

SUMMARY OF THE INVENTION

Following are some examples of some embodiments of the invention:

Example 1. A system for treating fat tissue, comprising:an ultrasound applicator, comprising:two or more ultrasound transducers configured to generate and directultrasonic waves to a selected tissue volume comprising fat tissue;a control unit, comprising:a memory;a control circuitry electrically connected to said two or moreultrasound transducers, wherein said control circuitry is configuredactivate said two or more ultrasound transducers in alternation and/orintermittently according to indications stored in said memory.Example 2. A system according to example 1, wherein said controlcircuitry activates said two or more ultrasound transducers according toan activation sequence stored in said memory.Example 3. A system according to any one of examples 1 or 2, whereinsaid ultrasound applicator comprises a housing having an inner lumen andat least one opening through a surface of said housing.Example 4. A system according to example 3, wherein an ultrasound energyemitting surface of said two or more ultrasound transducers face atleast partly said opening.Example 5. A system according to any one of examples 3 or 4, whereinsaid ultrasound applicator comprises a vacuum opening in said innerlumen, and wherein said vacuum opening is connected to a low-pressuresource.Example 6. A system according to example 5, wherein said control unit isconfigured to activate said low-pressure source for generatinglow-pressure levels within said inner lumen of the applicator during theactivation of said two or more ultrasound transducers.Example 7. A system according to any one of the previous examples,wherein said ultrasound applicator comprises at least one coolingelement attached to said two or more transducers, wherein said coolingelement is configured to cool a skin layer of a tissue contacting thetwo or more ultrasound transducers.Example 8. A system according to example 7, wherein said at least onecooling element comprises at least one TEC, and wherein a cold surfaceof said TEC is attached to a surface of each of said at least twoultrasound transducers or to a surface of at least one thermalconducting transducer holder attached to the two or more transducers.Example 9. A system according to example 7, wherein said ultrasoundapplicator comprises at least one cooling chamber comprising coolingliquid, wherein a hot surface of said at least one TEC is attached to asurface of said at least one cooling chamber, or to a surface of athermal conductive adaptor positioned between said hot surface of saidTEC and said at least one cooling chamber.Example 10. A system according to any one of the previous examples,wherein said ultrasonic waves are unfocused ultrasonic waves.Example 11. A system according to any one of the previous examples,wherein said control circuitry signals said two or more ultrasoundtransducers to generate said ultrasonic waves in frequency values in arange of 1-10 MHz.Example 12. A system according to any one of the previous examples,wherein said control circuitry signals said two or more ultrasoundtransducers to generate said ultrasonic waves with intensity values of5-90 W/cm{circumflex over ( )}2.Example 13. A method for treating fat tissue, comprising:delivering ultrasonic waves in alternation from at least twospaced-apart locations on the skin towards a selected tissue volume in atissue, wherein said selected tissue volume comprises fat tissue;cooling said skin during said delivery.Example 14. A method according to example 13, comprising:deforming a portion of said tissue during said delivering.Example 15. A method according to example 14, wherein said deformingcomprises applying vacuum on said tissue.Example 16. A method according to any one of examples 13 to 15,comprising heating said fat tissue to a temperature of at least 52° C.Example 17. A method according to any one of examples 13 to 16,comprising generating said ultrasonic waves with frequency values in arange of 1-10 MHz.Example 18. A method according to example 17, wherein said generatingcomprises generating said ultrasonic waves with frequency and/orintensity parameter values sufficient for penetrating into a depth of atleast 4 mm into said tissue.Example 19. A method according to any one of examples 13 to 18, whereinsaid ultrasonic waves are unfocused ultrasonic waves.Example 20. An assembly comprising:an ultrasound transducer having a body with a first surface and a secondsurface, and at least one channel crossing through said body from saidfirst surface and said second surface;a cooling element attached to said first surface of said body, whereinsaid cooling element is configured to cool a tissue contacting saidsecond surface through said at least one channel.Example 21. An assembly according to example 20, wherein said at leastone channel comprises a thermal conductive material connecting saidcooling element and said tissue.Example 22. An assembly according to any one of examples 20 or 21,comprising a flex PCB attached to said second surface of said ultrasoundtransducer.Example 23. An assembly according to example 22, wherein said flex PCBcomprises one or more temperature sensors positioned within said atleast one channel.

Following are some additional examples of some embodiments of theinvention:

Example 1. A system for treating fat tissue, comprising:an ultrasound applicator, comprising:two or more ultrasound transducers configured to generate and directultrasonic waves to a selected tissue volume comprising fat tissue;a control unit, comprising:a control circuitry electrically connected to said two or moreultrasound transducers, wherein said control circuitry is configured toactivate said two or more ultrasound transducers to heat said selectedtissue volume.Example 2. A system according to example 1, wherein said controlcircuitry activates said two or more ultrasound transducers inalternation and/or intermittently.Example 3. A system according to any one of examples 1 or 2, whereinultrasonic waves generated by said two or more ultrasound transducersconverge in said selected tissue volume.Example 4. A system according to any one of the previous examples,wherein said two or more ultrasound transducers are positioned at anangle smaller than 180 degrees relative to each other.Example 5. A system according to any one of the previous exampleswherein said control circuitry signals said two or more ultrasoundtransducers to generate said ultrasonic waves with intensity and/orfrequency parameter values suitable to penetrate to a depth of at least4 mm into said tissue volume.Example 6. A system according to any one of the previous examples,wherein said control circuitry signals said two or more transducers togenerate said ultrasonic waves with intensity and/or parameter valuessuitable to heat said tissue volume to at least 52° C. for a time periodof at least 15 seconds.Example 7. A system according to example 1, comprising a memory, whereinsaid control circuitry activates said two or more ultrasound transducersaccording to an activation sequence stored in said memory.Example 8. A system according to any one of the previous example,wherein said ultrasound applicator comprises a housing having an innerlumen and at least one opening through a surface of said housing.Example 9. A system according to example 8, wherein an ultrasound energyemitting surface of said two or more ultrasound transducers face atleast 10% of said opening.Example 10. A system according to any one of example 8 or 9, whereinsaid ultrasound applicator comprises a vacuum opening in said innerlumen, and wherein said vacuum opening is connected to a low-pressuresource.Example 11. A system according to example 10, wherein said control unitis configured to activate said low-pressure source for generatinglow-pressure levels within said inner lumen of the applicator during theactivation of said two or more ultrasound transducers.Example 12. A system according to any one of the previous examples,wherein said ultrasound applicator comprises at least one coolingelement attached to said two or more transducers, wherein said coolingelement is configured to cool a skin layer of a tissue contacting thetwo or more ultrasound transducers.Example 13. A system according to example 12, wherein a temperature ofsaid cooling element is in a range of −15° C. to −5° C.Example 14. A system according to any one of examples 12 or 13, whereinsaid at least one cooling element comprises at least one TEC, andwherein a cold surface of said TEC is attached to a surface of each ofsaid at least two ultrasound transducers or to a surface of at least onethermal conducting transducer holder attached to the two or moretransducers.Example 15. A system according to example 14, wherein said ultrasoundapplicator comprises at least one cooling chamber comprising coolingliquid, wherein a hot surface of said at least one TEC is attached to asurface of said at least one cooling chamber, or to a surface of athermal conductive adaptor positioned between said hot surface of saidTEC and said at least one cooling chamber.Example 16. A system according to example 7, wherein said controlcircuitry is configured to activate said two or more ultrasoundtransducers according to indications related to a thickness of said fattissue layers stored in said memory.Example 17. A system according to example 1, comprising a memory, andwherein said control circuitry is configured to activate said two ormore ultrasound transducers with activation parameters stored in saidmemory selected not to heat tissue layers adjacent in a depth directionto said fat tissue layerExample 18. A system according to example 17, wherein said activationparameters comprise one or more of ultrasonic waves frequency,ultrasonic waves intensity, ultrasonic waves angles, number of pulses ofsaid ultrasonic waves, duration of each pulse of said ultrasonic waves,number of pulses per day, overall ultrasonic energy per day, desiredtemperature at said selected tissue volume.Example 19. A system according to any one of the previous examples,wherein said ultrasonic waves are unfocused ultrasonic waves.Example 20. A system according to any one of the previous examples,wherein said control circuitry signals said two or more ultrasoundtransducers to generate said ultrasonic waves in frequency valuesselected from a range of 1-10 MHz.Example 21. A system according to any one of examples 1 to 19, whereinsaid control circuitry signals said two or more ultrasound transducersto generate said ultrasonic waves in frequency values selected from arange of 10-13 Mhz.Example 22. A system according to any one of the previous examples,wherein said control circuitry signals said two or more ultrasoundtransducers to generate said ultrasonic waves with intensity valuesselected from a range of 5-90 W/cm{circumflex over ( )}2. Example 23. Asystem according to any one of examples 1 to 21, wherein said controlcircuitry signals said two or more ultrasound transducers to generatesaid ultrasonic waves with intensity values selected from a range of 3-6Joules.Example 24. A system according to any one of the previous examples,wherein said control circuitry signals said two or more ultrasoundtransducers to generate and direct ultrasonic waves to a selected tissuevolume in the Chin and/or the Neck.Example 25. A system according to any one of the previous examples,wherein said control circuitry signals said two or more ultrasoundtransducers to generate and direct ultrasonic waves to a selected tissuevolume in the Abdomen and/or Chest.Example 26. A system according to any one of the previous examples,wherein said control circuitry signals said two or more ultrasoundtransducers to generate and direct ultrasonic waves to a selected tissuevolume in the Thighs and/or hands.Example 27. A system according to example 7, wherein said controlcircuitry is configured to activate said two or more ultrasoundtransducers with activation parameter values or indications thereofstored in said memory, selected to penetrate up to 7 mm from an externalsurface of the skin into said fat tissue.Example 28. A system according to example 7, wherein said controlcircuitry is configured to activate said two or more ultrasoundtransducers with activation parameter values or indications thereofstored in said memory, selected not to heat muscle layer located deeperthan said selected tissue volume.Example 29. A method for treating fat tissue, comprising: deliveringultrasonic waves from at least two spaced-apart locations on the skintowards a selected tissue volume in a tissue, wherein said selectedtissue volume comprises fat tissue; cooling said skin during and/orprior to said delivery.Example 30. A method according to example 29, wherein said deliveringcomprises delivering said ultrasonic waves in alternation from said atleast two spaced-apart locations on the skin towards said selectedtissue volume.Example 31. A method according to any one of examples 29 or 30,comprising: deforming a portion of said tissue during said delivering.Example 32. A method according to example 31, wherein said deformingcomprises applying vacuum on said tissue.Example 33. A method according to any one of examples 29 to 32,comprising heating said fat tissue to a temperature of at least 52° C.for at least 5 seconds.Example 34. A method according to any one of examples 29 to 33,comprising generating said ultrasonic waves with frequency valuesselected from a range of 1-10 MHz.Example 35. A method according to any one of examples 29 to 33,comprising generating said ultrasonic waves with frequency valuesselected from a range of 10-13 MHz.Example 36. A method according to any one of examples 29 to 35,comprising sensing fat tissue from at least one of said two spaced-apartlocations on the skin.Example 37. A method according to example 36, comprising adjustingangles of said ultrasonic waves according to said sensed location ofsaid fat tissue.Example 38. A method according to any one of example 36 or 37,comprising generating said ultrasonic waves with frequency and/orintensity values according to said determined depth of said fat tissue.Example 39. A method according to any one of example 34 or 35, whereinsaid generating comprises generating said ultrasonic waves withfrequency and/or intensity parameter values sufficient for penetratinginto a depth of at least 4 mm into said tissue.Example 40. A method according to any one of examples 29 to 39,comprising evaluating an effect of said delivering on said skin duringand/or following said delivering.Example 41. A method according to example 40, wherein said effectcomprises at least one side effect, and wherein said method comprisesadjusting one or more of intensity, frequency and duration of saidultrasonic waves to reduce said at least one side effect.Example 42. A method according to any one of examples 29 to 41, whereinsaid ultrasonic waves are unfocused ultrasonic waves.Example 43. A method according to any one of examples 29 to 42, whereinsaid method is applied to healthy subjects not suffering from afunctional problem.Example 44. An assembly comprising:an ultrasound transducer having a body with a first upper surface and asecond lower surface, and at least one channel crossing through saidbody from said first upper surface to said second lower surface;a cooling element attached to said first upper surface of said body,wherein said cooling element is configured to cool a tissue contactingsaid second lower surface through said at least one channel.Example 45. An assembly according to example 44, wherein said at leastone channel comprises a thermal conductive material connecting saidcooling element and said tissue.Example 46. An assembly according to any one of examples 44 or 45,comprising an electrical circuitry attached to said second lower surfaceof said ultrasound transducer.Example 47. An assembly according to example 46, wherein said electricalcircuitry comprises one or more temperature sensors positioned withinsaid at least one channel.Example 48. A method for delivery of skin treatment, comprising:selecting a treatment target for an ultrasound treatment located at alayer of the skin, wherein said ultrasound treatment is an unfocusedultrasound treatment;adjusting values of one or more ultrasound treatment parametersaccording to said selected treatment target to avoid damage to adifferent layer of the skin;delivering said ultrasound treatment to said treatment target.Example 49. A method according to example 48, wherein said selectingcomprises selecting two or more treatment targets for an ultrasoundtreatment located at different layers of the skin, and wherein adjustingcomprises adjusting values of a one or more ultrasound treatmentparameters according to said selected two or more treatment targets,wherein parameter values of an ultrasound treatment for treating a firsttreatment target of said two or more treatment targets are differentfrom parameter values of an ultrasound treatment for treating a secondtreatment target of said two or more treatment targets;Example 50. A method according to example 49, wherein said two or moretreatment targets are located at one or more of epithelium layer,epidermis layer, hypodermis layer and lamina propria layer.Example 51. A method according to any one of examples 48 to 50, whereinsaid one or more ultrasound treatment parameters comprise one or more ofultrasound waves frequency, ultrasound waves intensity, time period ofultrasound waves delivery.Example 52. A method for targeting a fat tissue layer within skin,comprising;determining a location of said fat tissue layer within said skin tissue;calculating one or more of intensity, frequency and time duration valuesof unfocused ultrasonic waves to heat said fat tissue layer at saiddetermined location without heating tissue layers located deeper thansaid fat tissue layer.Example 53. A method according to example 52, wherein said determiningcomprises determining a thickness of said fat tissue layer and/orlocation of said deeper tissue layers.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

As will be appreciated by one skilled in the art, some embodiments ofthe present invention may be embodied as a system, method or computerprogram product. Accordingly, some embodiments of the present inventionmay take the form of an entirely hardware embodiment, an entirelysoftware embodiment (including firmware, resident software, micro-code,etc.) or an embodiment combining software and hardware aspects that mayall generally be referred to herein as a “circuit,” “module” or“system.” Furthermore, some embodiments of the present invention maytake the form of a computer program product embodied in one or morecomputer readable medium(s) having computer readable program codeembodied thereon. Implementation of the method and/or system of someembodiments of the invention can involve performing and/or completingselected tasks manually, automatically, or a combination thereof.Moreover, according to actual instrumentation and equipment of someembodiments of the method and/or system of the invention, severalselected tasks could be implemented by hardware, by software or byfirmware and/or by a combination thereof, e.g., using an operatingsystem.

For example, hardware for performing selected tasks according to someembodiments of the invention could be implemented as a chip or acircuit. As software, selected tasks according to some embodiments ofthe invention could be implemented as a plurality of softwareinstructions being executed by a computer using any suitable operatingsystem. In an exemplary embodiment of the invention, one or more tasksaccording to some exemplary embodiments of method and/or system asdescribed herein are performed by a data processor, such as a computingplatform for executing a plurality of instructions. Optionally, the dataprocessor includes a volatile memory for storing instructions and/ordata and/or a non-volatile storage, for example, a magnetic hard-diskand/or removable media, for storing instructions and/or data.Optionally, a network connection is provided as well. A display and/or auser input device such as a keyboard or mouse are optionally provided aswell.

Any combination of one or more computer readable medium(s) may beutilized for some embodiments of the invention. The computer readablemedium may be a computer readable signal medium or a computer readablestorage medium. A computer readable storage medium may be, for example,but not limited to, an electronic, magnetic, optical, electromagnetic,infrared, or semiconductor system, apparatus, or device, or any suitablecombination of the foregoing. More specific examples (a non-exhaustivelist) of the computer readable storage medium would include thefollowing: an electrical connection having one or more wires, a portablecomputer diskette, a hard disk, a random access memory (RAM), aread-only memory (ROM), an erasable programmable read-only memory (EPROMor Flash memory), an optical fiber, a portable compact disc read-onlymemory (CD-ROM), an optical storage device, a magnetic storage device,or any suitable combination of the foregoing. In the context of thisdocument, a computer readable storage medium may be any tangible mediumthat can contain, or store a program for use by or in connection with aninstruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signalwith computer readable program code embodied therein, for example, inbaseband or as part of a carrier wave. Such a propagated signal may takeany of a variety of forms, including, but not limited to,electro-magnetic, optical, or any suitable combination thereof. Acomputer readable signal medium may be any computer readable medium thatis not a computer readable storage medium and that can communicate,propagate, or transport a program for use by or in connection with aninstruction execution system, apparatus, or device.

Program code embodied on a computer readable medium and/or data usedthereby may be transmitted using any appropriate medium, including butnot limited to wireless, wireline, optical fiber cable, RF, etc., or anysuitable combination of the foregoing.

Computer program code for carrying out operations for some embodimentsof the present invention may be written in any combination of one ormore programming languages, including an object oriented programminglanguage such as Java, Smalltalk, C++ or the like and conventionalprocedural programming languages, such as the “C” programming languageor similar programming languages. The program code may execute entirelyon the user's computer, partly on the user's computer, as a stand-alonesoftware package, partly on the user's computer and partly on a remotecomputer or entirely on the remote computer or server. In the latterscenario, the remote computer may be connected to the user's computerthrough any type of network, including a local area network (LAN) or awide area network (WAN), or the connection may be made to an externalcomputer (for example, through the Internet using an Internet ServiceProvider).

Some embodiments of the present invention may be described below withreference to flowchart illustrations and/or block diagrams of methods,apparatus (systems) and computer program products according toembodiments of the invention. It will be understood that each block ofthe flowchart illustrations and/or block diagrams, and combinations ofblocks in the flowchart illustrations and/or block diagrams, can beimplemented by computer program instructions. These computer programinstructions may be provided to a processor of a general purposecomputer, special purpose computer, or other programmable dataprocessing apparatus to produce a machine, such that the instructions,which execute via the processor of the computer or other programmabledata processing apparatus, create means for implementing thefunctions/acts specified in the flowchart and/or block diagram block orblocks.

These computer program instructions may also be stored in a computerreadable medium that can direct a computer, other programmable dataprocessing apparatus, or other devices to function in a particularmanner, such that the instructions stored in the computer readablemedium produce an article of manufacture including instructions whichimplement the function/act specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer,other programmable data processing apparatus, or other devices to causea series of operational steps to be performed on the computer, otherprogrammable apparatus or other devices to produce a computerimplemented process such that the instructions which execute on thecomputer or other programmable apparatus provide processes forimplementing the functions/acts specified in the flowchart and/or blockdiagram block or blocks.

Some of the methods described herein are generally designed only for useby a computer, and may not be feasible or practical for performingpurely manually, by a human expert. A human expert who wanted tomanually perform similar tasks, such as controlling the activation ofultrasound transducers to heat a deep layer of fat tissue, might beexpected to use completely different methods, e.g., making use of expertknowledge and/or the pattern recognition capabilities of the humanbrain, which would be vastly more efficient than manually going throughthe steps of the methods described herein.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a is a flow chart of a general process for treating tissue,according to some exemplary embodiments of the invention;

FIG. 2A is a block diagram of a system for delivery of ultrasonic energytreatment, according to some exemplary embodiments of the invention;

FIG. 2B is an image showing a distance and/or orientation between one ormore transducers and a target tissue volume, according to some exemplaryembodiments of the invention;

FIGS. 2C and 2D are schematic illustrations of different treatmentregions of the human body, according to some exemplary embodiments ofthe invention;

FIG. 2E is a schematic illustration of different ultrasound applicatorsat some of the treatment regions shown in FIGS. 2C and 2D, according tosome exemplary embodiments of the invention;

FIG. 2F is a flow chart of one or more treatment procedures, accordingto some exemplary embodiments;

FIG. 2G is an overall treatment scheme, according to some exemplaryembodiments of the invention;

FIG. 3A is a flow chart of a detailed process for treating tissue byultrasonic energy, according to some exemplary embodiments of theinvention;

FIG. 3B is a schematic illustration showing from a bottom view anultrasound applicator, according to some exemplary embodiments of theinvention;

FIG. 4A is a schematic cross-section view of an applicator with anopening having a plurality of ultrasonic transducers and a low pressuresource, according to some exemplary embodiments of the invention;

FIG. 4B is a schematic cross-section view of the applicator shown inFIG. 4A placed in contact with a target tissue, according to someexemplary embodiments of the invention;

FIG. 5A is a schematic cross-section view of an applicator with anopening having a plurality of ultrasonic transducers facing the opening,according to some exemplary embodiments of the invention;

FIG. 5B is a schematic cross-section view of the applicator shown inFIG. 5A placed in contact with a target tissue, according to someexemplary embodiments of the invention;

FIG. 6A is a schematic cross-section view of an applicator with anopening having a plurality of ultrasonic transducers facing the openingand a large contact area between TECs and thermal energy conductingelements, according to some exemplary embodiments of the invention;

FIG. 6B is a schematic cross-section view of the applicator shown inFIG. 6A placed in contact with a target tissue, according to someexemplary embodiments of the invention;

FIG. 6C is a schematic illustration showing an array of ultrasoundtransducers, according to some exemplary embodiments of the invention;

FIG. 7A is a schematic illustration of an ultrasound transducer havingcrossing through openings, according to some exemplary embodiments ofthe invention;

FIG. 7B is a schematic cross-section view of an assembly of a coolingelement attached to a surface of the ultrasound transducer shown in FIG.7A, according to some exemplary embodiments of the invention;

FIG. 7C is a schematic cross-section view of the assembly shown in FIG.7B having cooling pillars passing through the openings in the ultrasoundtransducer, according to some exemplary embodiments of the invention;

FIG. 7D is a schematic cross-section view of the assembly shown in FIG.7C having low thermal conductivity elements between the cooling pillarsand the external surface of the applicator, according to some exemplaryembodiments of the invention;

FIG. 7E is a schematic cross-section view of the assembly shown in FIG.7D having one or more temperature sensors, according to some exemplaryembodiments of the invention;

FIG. 7F is a histochemical cross-section image showing boundariesbetween the fat tissue layer, for example the hypodermis layer andadjacent tissue layers, according to some exemplary embodiments of theinvention;

FIG. 7G is a flow chart of a process for targeting the fat tissue layer,according to some exemplary embodiments of the invention;

FIG. 7H is a schematic cross-section illustrations of skin layers, forexample skin layers related to cellulite treatment, according to someexemplary embodiments of the invention;

FIG. 8A is a graph of simulation results, according to some exemplaryembodiments of the invention;

FIGS. 8B to 8E are simulation results when emitting ultrasonic waves ina frequency of 2 MHz, according to some exemplary embodiments of theinvention;

FIG. 9A is a graph of simulation results, according to some exemplaryembodiments of the invention;

FIGS. 9B to 9E are simulation results when emitting ultrasonic waves ina frequency of 5 MHz, according to some exemplary embodiments of theinvention;

FIGS. 10A-10E, 11A-11D, 12A-12D, 13A-13D are images of face regionsbefore and after treatment delivered during an experiment;

Table A summarized treatment parameter values when emitting ultrasonicwaves in a frequency of 2 MHz, according to some exemplary embodimentsof the invention; and

Table B summarizes treatment parameter values when emitting ultrasonicwaves in a frequency of 5 MHz, according to some exemplary embodimentsof the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to fattissue treatment, for example a cosmetic fat tissue treatment and, moreparticularly, but not exclusively, to fat tissue treatment usingultrasonic energy.

An aspect of some embodiments relates to heating a selected tissuevolume comprising fat tissue located under the skin by a plurality ofultrasonic waves, for example unfocused ultrasonic waves, directedtowards the selected tissue volume. As used herein the term unfocusedmeans non-converging. In some embodiments, unfocused ultrasonic wavesare ultrasonic waves, which are not focused to converge in twodimensions. In some embodiments, fat tissue comprises cellulite. In someembodiments, the ultrasonic waves are generated by two or moreultrasound transducers operating in alternation optionally in a repeatedor a non-repeated sequence, for example to continuously heat the tissuevolume while keeping the skin contacting the transducers cool.Alternatively or additionally, the ultrasonic waves are generated byintermittently activating one or more ultrasound transducers.

According to some embodiments, at least some of the ultrasonic wavescross each other. In some embodiments, the crossing point is located inthe selected tissue volume. In some embodiments, the ultrasonic wavesare emitted with a shift of at least 1° from a line of sight.Optionally, the ultrasonic waves are emitted with a shift of at least 1°from a line of sight relative to other ultrasonic waves.

According to some embodiments, at least some of the ultrasonic wavescontact the selected tissue volume at spaced apart contact pointspositioned at a distance of up to 20 cm from each other, for example upto 10 cm, up to 5 cm, up to 2 cm, up to 0.1 cm or any intermediate,smaller or larger value, in the selected tissue volume.

According to some embodiments, the selected tissue volume has a maximaldimension value, for example maximal length, maximal width, maximaldiameter, maximal thickness of up to 25 cm, for example up to 20 cm, upto 10 cm, up to 1 cm, up to 0.1 cm or any intermediate smaller or largervalue.

According to some embodiments, the ultrasonic waves are generated by twoor more ultrasound transducers positioned on top the skin. In someembodiments, the two or more ultrasound transducers are in directcontact with the skin. Alternatively, the two or more ultrasoundtransducers transmit the ultrasonic waves through a cover placed indirect contact with the skin.

According to some embodiments, the ultrasonic waves directed to theselected tissue volume are generated with intensity and frequency levelssufficient to affect the structure and/or stability of the fat tissue.In some embodiments, the ultrasonic waves heat the fat tissue totemperature levels in a range of 45-85° C., for example to temperaturelevels in a range of 45-55° C., 52-57° C., 50-70° C., 60-85° C., or anyintermediate smaller or larger temperature value or range oftemperatures. In some embodiments and without being bound by any theory,heating the fat tissue to these temperature levels causes death ofadipose tissue, and specifically apoptosis of fat cells due to theheating. Optionally the heating causes damage to the micro-vasculaturethat supply blood to the fat cells, thus causing them to die.Optionally, during the heating of the fat tissue, the epidermis layerremains in a temperature level of up to 55° C.

According to some embodiments, the two or more ultrasound transducersgenerate ultrasonic waves in a frequency range of 1-10 MHz, for example,in a frequency range of 1-5 MHz, 3-7 MHz, 5-10 MHz or any intermediate,smaller or larger value or range of values.

According to some embodiments, the two or more ultrasound transducersgenerate ultrasonic waves in an intensity range of 5-90 W/cm{circumflexover ( )}2, for example 5-20 W/cm{circumflex over ( )}2, 10-30W/cm{circumflex over ( )}2, 40-90 W/cm{circumflex over ( )}2 or anyintermediate, smaller or larger value or range of values. In someembodiments, the two or more transducers deliver energy in a range of1-18 Joules to the tissue.

According to some embodiments, the two or more ultrasound transducersgenerate high ultrasonic energy levels in the target tissue volume, withoptionally lower energy levels on the skin surface. In some embodiments,the two or more ultrasound transducers generate the ultrasonic waveswith low frequency, for example frequency values in a range of 1-5 MHz,for example, frequency values in a range of 1-2 MHz, 2-4 MHz, 3-5 MHz orany intermediate, smaller or larger range of values. In someembodiments, the low frequency ultrasonic waves allow deeper penetrationinto the tissue with less absorption in dermis and fascia. In someembodiments, the low frequency ultrasonic waves generate, for example,cavitation. In some embodiments, the cavitation is used, for example, toincrease the ultrasonic energy absorption of the tissue.

According to some embodiments, the two or more ultrasound transducersgenerate the ultrasonic waves with higher frequency levels, for example,frequency levels in a range of 4-10 MHz, for example frequency levels inthe range of 4-5 MHz, 5-6 MHz, 6-10 MHz or any intermediate, smaller orlarger range of values. In some embodiments and without being bound byany theory, the high frequency ultrasonic waves intensify the absorptionof the ultrasonic energy within the tissue, and optionally the heatingof the tissue.

According to some embodiments, each ultrasound transducer generatesultrasonic waves with different frequencies, for example differences ina range of 0.1-2 MHz. In some embodiments, the generated ultrasonicwaves with the different frequencies allow to create acoustic beats. Insome embodiments and without being bound by any theory, the acousticbeats allow, for example, to generate a low frequency that is half ofthe difference between the original two frequencies, and frequency thatis the average of the original two frequencies. The low frequency cangenerate cavitation, which enhances absorption of ultrasonic energy inthe tissue volume which is applied by the two frequencies.

According to some embodiments, one or more of a plurality of theultrasound transducers are activated at a given time. In someembodiments, ultrasonic waves generated by the plurality of ultrasoundtransducers are directed towards the same tissue volume, which includesfat tissue. In some embodiments, at least two ultrasound transducersfacing the tissue volume are activated for a pre-determined time beforeswitching to different ultrasound transducers, for example at least twodifferent ultrasound transducers of the same ultrasound applicator. Insome embodiments, one or more ultrasound transducers of the applicator,facing the tissue volume, are intermittently activated. In someembodiments, an ultrasound energy emitting surface of said one or moreultrasound transducers faces the tissue volume. Alternatively oradditionally, two or more ultrasound transducers of the applicator areactivated in alternation, optionally in a repeated or a non-repeatedsequence.

According to some embodiments, the activation period of each group oftransducers is determined based on the temperature of the skin near thetransducers, for example to minimize thermal damage of the skin. In someembodiments, activating different ultrasound transducers optionallygroups of transducers in a sequence, one after the other, allows forexample, to minimize thermal damage to the skin while continuouslyheating the deep tissue volume. In addition, it allows more efficientcooling of deactivated transducers.

According to some embodiments, each transducer or a group oftransducers, for example 2 transducers, 3 transducers, 4 transducers orany larger number of transducers deliver a sequence of ultrasonic energypulses to the tissue volume. In some embodiments, each transducer or agroup of transducers are activated with zero emission windows betweenactivation sequences. In some embodiments, during the delivery of theultrasonic energy to the issue volume, some of the transducers, forexample one or more of the transducers are deactivated while othertransducers, for example one or more of the transducers are activated.

According to some embodiments, intermittently activating one or moretransducers and/or activating the transducers in alternation allows forexample, to cool thick transducers, for example thick piezoelectric(PZT) plates of the transducers. As used herein, the term PZT relates toany piezo-electric material that is used to generate ultrasound. In someembodiments, the thick PZT plates are cooled by a cool surface of acooling element, for example the cool surface of a thermoelectric cooler(TEC). In some embodiments, cooling down the PZT plates allows, forexample, to cool down the epidermis layer placed in contact with theultrasound transducers.

According to some embodiments, the tissue is deformed into a desiredgeometrical shape while delivering the ultrasonic energy to the tissuevolume. In some embodiments, the tissue is deformed, for example toensure a better contact between the ultrasound transducers and thetissue. Alternatively or additionally, the tissue is deformed, forexample, to better align the ultrasound transducer and the target tissuevolume located deep inside the tissue.

According to some embodiments, the tissue is deformed by pressureapplied by a mechanical assembly, for example clamps. In someembodiments, the tissue is held between two clamps, optionallycomprising one or more transducers placed between the clamps ad thetissue.

According to some embodiments, the tissue is deformed by applyingnegative pressure, for example vacuum, on the tissue. As used herein,the term vacuum refers to pressure levels, which are lower thanatmospheric pressure. In some embodiments, a negative pressure outlettube is positioned near the tissue surface. In some embodiments,application of vacuum causes the tissue to bend through one or moreopenings in the ultrasound applicator, optionally without contacting anopening of the negative pressure outlet tube.

According to some embodiments, vacuum is stably applied on the tissue.In some embodiments, vacuum application during ultrasound energydelivery causes stretching of the skin. In some embodiments, stretchingof the skin during ultrasound energy delivery increases thermal damageeffect on collagen fibers in the tissue. In some embodiments, vacuumapplication allows, for example, to press the skin against the externalface of the ultrasonic transducers. In some embodiments, pressing theskin against the transducers allows to minimize the general thickness ofthe tissue. Alternatively or additionally, pressing the skin against thetransducers allows better acoustic contact and/or better thermal contactbetween the transducers and the tissue.

According to some embodiments, the tissue is vibrated during thedelivery of the ultrasonic energy to the issue volume. In someembodiments, the tissue is vibrated by a vibrator attached to theapplicator. Alternatively, the tissue is vibrated by applying vacuumintermittently. Optionally, the tissue is vibrated by changing levels ofthe negative pressure applied on the tissue.

According to some embodiments, the tissue vibration stretches and/orelongates collagen fibers in the tissue. Alternatively or additionally,the vibration decreases tissue perfusion, which optionally increasesultrasonic tissue heating.

An aspect of some embodiments relates to delivery of ultrasonic energyto a tissue volume using one or more ultrasound transducers having oneor more cross through openings, for example cross-through channels. Insome embodiments, the ultrasonic energy is delivered using the one ormore ultrasound transducers while cooling layers of the skin, forexample the epidermis layer of the skin. In some embodiments, tissuevolume is a deep tissue volume and optionally comprises fat tissue. Insome embodiments the one or more cross-through openings, for example oneor more cross-through channels, crossing through a PZT plate of the oneor more ultrasound transducers. Optionally, the one or morecross-through channels cross the PZT plate from one surface to anothersurface of the PZT plate.

According to some embodiments, a cooling element, for example a coolsurface of a TEC and/or a surface of a cooling basement attached to afirst surface of the one or more ultrasound transducers cool the skincontacting a second surface of the one or more transducers through thechannels. In some embodiments, the channels are filled at least partlywith a thermal conducting material, for example Aluminum, Iron, Copper,Silver, Gold, Alumina past.

According to some embodiments, the filled channels form cooling pillarsbetween the cooling element and the skin. In some embodiments, thethermal conducting material in the cooling pillars conducts cold fromthe first surface to the second surface of the one or more transducers.In some embodiments, at least some of the cooling pillars comprisethermal isolators, for example to control the cooling level of the skinand optionally to avoid over cooling of the skin. In some embodiments,conducting cold through the cooling pillars allows, for example, toprotect the epidermis layer of the skin from over-heating during thedelivery of the ultrasonic energy. Alternatively or additionally,conducting cold through the cooling pillars allows, for example, to coolthe dermis in order to avoid extensive continuous thermal damage.

According to some embodiments, a flex printed circuit board (PCB),optionally a thin flex PCB, comprising one or more thermistorsconfigured to measure epidermal temperature, is attached to the secondsurface of the transducers. Optionally, the one or more thermistors arepositioned within the channels. In some embodiments, the one or morethermistors are positioned within the cooling pillars.

According to some embodiments, the one or more channels are filled witha plurality of heat conducting materials, at different heat conductivityconstants, for example Aluminum, Iron, Copper, Silver, Gold, Aluminapast, positioned on the cooling plate. Alternatively or additionally,the one or more channels are filled with multi-layered stacks ofmaterials positioned on the cooling plate. In some embodiments, thematerials are used for cooling the tissue and/or for cooling the PZT.

According to some embodiments, the one or more crossing-through channelsare empty. In some embodiments, the empty channels allow, for example,to apply vacuum on the skin surface through the channels. In someembodiments, applying vacuum through the channels allows, for example,better acoustic and/or better thermal contact with the skin.

According to some embodiments, a flex PCB, optionally a flex thin PCB,comprising one or more thermistors is attached to the second surface ofthe ultrasound transducer. In some embodiments, the one or morethermistors are positioned within the empty channels and are configuredto measure temperature levels of the skin contacting the ultrasoundtransducer. In some embodiments, temperature measurements using thethermistors allows, for example, to protect the skin layers, for examplethe epidermis from over-heating and/or over cooling. Alternativelyand/or additionally, measurements through the empty channels allow, forexample, evaluation of acoustic and thermal contact with the skin.

According to some embodiments, having an ultrasound transducer withcrossing-through channels, allows, for example to avoid overheating ofthe epidermis in temperature pick points on the PZT surface.

A potential advantage of using an ultrasound transducers with channelsis that it allows to use thick ultrasound transducers, which generateultrasonic energy with high intensity while controlling and/or coolingthe temperature of the skin through the opening as abovementioned.

According to some embodiments, the applicator is connected to one ormore fixtures and/or set-ups, configured to allow stand-alonepositioning of the applicator against the skin. In some embodiments, thefixtures comprise at least one elastic band, for example at least oneelastic band shaped and sized for positioning around the torso or alimb. In some embodiments, the one or more fixtures comprise at leastone external elongated arm connected on one end to a system console, andconfigured to hold a plate with several treatment heads, for exampleseveral ultrasound applicators. In some embodiments, one or more vacuumcups are connected to the applicator head, for example to attach thevacuum head to the skin.

An aspect of some embodiments relates to targeting a fat tissue layer ofthe skin with ultrasonic energy. In some embodiments, the fat tissuelayer is targeted by determining a depth of the fat tissue layer fromthe external surface of the skin. Additionally, the fat tissue layer istargeted by determining boundaries location of the fat tissue layer withupper and lower tissue layers contacting the fat tissue layer, forexample a dermis layer and a muscle layer.

According to some embodiments, the fat tissue layer is targeted based onan anatomical location, and an average depth of the fat tissue layerfrom the external surface of the skin at the anatomical location. Insome embodiments, the anatomical position comprises the Chin, left Neck,right Neck, Submental space, inner Thigh, outer Thigh, Buttocks, Chestand Abdomen. In some embodiments, by selecting a specific anatomicallocation, a depth, for example an average depth, of the fat tissue layeris determined. Optionally, by selecting a specific anatomical location,a width of the tissue layer, for example an average width of the fattissue layer and/or location of the fat tissue layer boundaries at thespecific anatomical location are determined. In some embodiments,treatment parameter values, for example ultrasonic waves intensity,ultrasonic waves frequency, ultrasonic waves angles, number and/orduration of ultrasonic waves pulses are adjusted, optionallyautomatically by a control unit of an ultrasound applicator based on theselected anatomical position.

According to some exemplary embodiments, the fat tissue layer istargeted, for example by scanning tissue layers for example deep tissuelayers underneath a selected position on the external surface of theskin. In some embodiments, a scanner, for example an ultrasound scanneror an ultrasound probe is positioned at a selected position on theexternal surface of the skin, and scans deep tissue layers. In someembodiments, the fat tissue layer, and/or fat tissue boundaries withadjacent tissue layers are identified in the scans. In some embodiments,a depth, and/or a width of the fat tissue layer at the selected positionon the external surface of the skin are calculated based on the scans.In some embodiments, location of the fat tissue layer boundaries withadjacent tissue layers are calculated based on the scans. In someembodiments, treatment parameter values, for example ultrasonic wavesintensity, ultrasonic waves frequency, ultrasonic waves angles, numberand/or duration of ultrasonic waves pulses are adjusted based on thescans.

An aspect of some embodiments relates to delivery of ultrasonic energyto one or more deep tissue layers of the skin for treating cellulite. Insome embodiments, the delivered ultrasonic energy, for example unfocusedultrasonic energy, disrupts the deep tissue layers formation by heatingdeep tissue layers to a desired temperature level while cooling theexternal surface of the skin. In some embodiments, the deep tissuelayers comprise fat tissue layer and/or connective tissue, for exampleconnective tissue between fat cells.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Exemplary General Treatment Process

According to some exemplary embodiments, ultrasonic energy is directedfrom one or more ultrasound transducers of an ultrasound applicatortowards a selected tissue volume, optionally comprising fat tissue. Insome embodiments, in order to ensure close contact between theultrasound applicator and the tissue, the tissue is deformed during thedelivery of the ultrasonic energy. In some embodiments, deformation ofthe tissue, presses the tissue against the ultrasound transducer and/oragainst a surface of the applicator. In some embodiments, the ultrasoundenergy is delivered to the selected tissue volume by two or moreultrasound transducers that are activated intermittently and/or inalternation, for example to ensure continuous heating of the tissuevolume while cooling the skin contacting a temporary inactive ultrasoundtransducer. Alternatively, the two or more ultrasound transducer worksimultaneously, for example during more than 30% of their activationperiod. Reference is now made to FIG. 1 depicting a general process fortreating deep tissue layers, according to some exemplary embodiments ofthe invention.

According to some exemplary embodiments, a selected target tissue isdeformed at 102. In some embodiments, the tissue is deformed by applyingnegative pressure, for example vacuum on the tissue. Alternatively oradditionally, the tissue is deformed by pressing an ultrasoundapplicator with a distorted external surface, for example with a curvedexternal surface, against the tissue.

According to some exemplary embodiments, at least part of the ultrasoundapplicator is placed in contact with the skin at 104. In someembodiments, deforming the tissue at 102 allows, for example, a closecontact between one or more ultrasound transducers of the ultrasoundapplicator and the skin. Alternatively or additionally, deforming thetissue at 102 allows, for example, to align one or more ultrasoundtransducers with a selected tissue volume within the selected targettissue.

According to some exemplary embodiments, ultrasound waves are emitted byactivating two or more ultrasound transducers in alternation and/orintermittently, towards the selected tissue volume at 106. In someembodiments, the ultrasound waves are emitted from one or moreultrasound transducers while other ultrasound transducers of theapplicator are temporary inactive. In some embodiments, the ultrasoundwaves are emitted while the tissue is at least partly deformed.

According to some exemplary embodiments, the tissue contacting theapplicator and/or one or more of the transducers of the applicator iscooled in a timed relationship with the emitting of ultrasound waves, at108. In some embodiments, the tissue contacting the applicator, forexample the skin and/or the epidermis layer of the skin is cooled at108. In some embodiments, the tissue contacting the transducer is cooledduring and/or after the delivery of ultrasonic energy to the tissue. Insome embodiments, the tissue contacting the transducer is cooled throughone or more openings in the transducer. Alternatively or additionally,the tissue contacting the transducer is cooled by at least one coolingelement, for example a TEC and/or a thermal conducting element attachedto the one or more of the transducers.

According to some exemplary embodiments, the emitted ultrasound wavesheat deep tissue layers at 110. In some embodiments, the deep tissuelayers are heated to a temperature level in a range of 45-85° C., forexample to a temperature level the range of 45-55° C., 52-57° C., 56-70°C., 65-85° C. or any intermediate, smaller or larger range oftemperatures. In some embodiments, the deep tissue layers are positionedat a depth of 1-30 mm, for example at a depth of 2-20 mm, 5-30 mm or anyintermediate, smaller or larger value, from the skin. In someembodiments, the deep tissue layers comprise fat tissue. In someembodiments and without being bound by any theory, heating fat tissue toa temperature in a range of 45-85° C., for example to a temperaturerange of 45-75° C., 52-57° C., 53-85° C. or any intermediate, smaller orlarger range of temperatures, causes lipolysis of the fat tis sue.

According to some exemplary embodiments, the applicator is moved to adifferent region on the skin at 112. In some embodiments, the applicatoris moved to a different location when tissue deformation and/or emittingof ultrasound waves is stopped. Optionally, the applicator is moved to adifferent region when the ultrasound waves are emitted during apre-determined time period. Alternatively or additionally, theapplicator is moved when temperature levels at the contact site betweenthe transducers and the skin are higher than a pre-determinedtemperature level, for example above 37° C., for example above 42° C.

Exemplary System for Treating Fat Tissue

Reference is now made to FIG. 2A, depicting a system for treating aselected tissue volume comprising fat tissue, according to someexemplary embodiments of the invention.

According to some exemplary embodiments, a system for treating fattissue, for example system 200 comprises a control console, for examplecontrol unit 202 and at least one ultrasound applicator, for exampleapplicator 204. In some embodiments, applicator 204 comprises one ormore ultrasound transducers, for example transducers 208 located atleast partly within housing 206 of the applicator. In some embodiments,at least part of the transducers 208 extends out from the housing 206.In some embodiments, the transducers are spaced-apart and aredistributed on the surface of the applicator. In some embodiments, eachtransducer of transducers 208 has a surface area in a range of 2×2mm-20×20 mm, for example 5×5 mm, 10×10 mm or any intermediate, smalleror larger value.

According to some exemplary embodiments, the ultrasound applicator, forexample applicator 204, has a maximal dimension, for example length ordiameter in a range of 20-200 mm, for example in a range of 20-100 mm,50-150 mm, 100-200 mm or any intermediate, smaller or larger value orrange of values. In some embodiments, the ultrasound applicator, forexample applicator 204 has a thickness in a range of 10-200 mm, forexample in a range of 10-100 mm, 50-150 mm, 100-200 mm or anyintermediate, smaller or larger value or range of values.

According to some exemplary embodiments, at least some transducers oftransducers 208 have a transducer assembly comprising a PZT and one ormore electrical connections. Optionally, the transducer assemblycomprises at least one coating, for example coating of the PZT. In someembodiments, a thickness of the transducer assembly is in a range of0.1-7 mm, for example in a range of 0.1-0.8 mm, 0.3-2 mm, 0.3-5 mm orany intermediate, smaller or larger value or range of values. In someembodiments, a thickness of a PZT is in a range of 0.1-5 mm, for examplein a range of 0.1-2 mm, 0.2-3 mm, 0.5-5 mm or any intermediate, smalleror larger value or range of values.

According to some exemplary embodiments, the applicator 204 comprises atleast one thermal conducting element. In some embodiments, thetransducers 208 are attached to the at least one thermal conductingelement, for example thermal conductor 210. In some embodiments, asurface of the one or more transducers 208 is attached to a surface ofthe thermal conductor 210. In some embodiments, a single thermalconductor is attached to two or more transducers. In some embodiments,the thermal conductor 210 is made from a thermal conductive material,for example Aluminum or Copper.

According to some exemplary embodiments, the applicator 204 comprises atleast one cooling element, for example TEC 212. In some embodiments, acold surface of the TEC is attached to a surface of the thermalconductor 210. Alternatively, a cold surface of the TEC is attached tothe one or more ultrasound transducers 208. In some embodiments, thethermal conductor delivers cold from the cold surface of the TEC to theone or more transducers, optionally through the thermal conductor 210.In some embodiments, the TEC, for example TEC 212 has a surface area ina range of 10×10 mm-50×50 mm, for example 20×20 mm, 40×20 mm or anyintermediate, smaller or larger surface area.

According to some exemplary embodiments, the applicator 204 comprises acooling chamber, for example cooling chamber 214. In some embodiments,the cooling chamber 214 comprises cooling liquid, for example water. Insome embodiments, the cooling chamber 214 is fluidically connected to acooling system in the console by tubing 216. In some embodiments, thecooling chamber 214, for example a surface of the cooling chamber 214 isattached to a hot surface of the TEC 212. In some embodiments, heat isconducted from the hot surface of TEC 212 to the cooling liquid in thecooling chamber 214. In some embodiments, the cooling liquid iscirculated between the cooling chamber 214 and the cooling system 218 ofthe control unit 202 via tubing 216.

According to some exemplary embodiments, the applicator 204 comprises atleast one inlet of a low pressure source, for example inlet 235. In someembodiments, the inlet is connected to a low-pressure source 237, forexample a vacuum pump in the control unit 202. Alternatively, thelow-pressure source 237 is external to the control unit 202. In someembodiments, the low pressure source 237 is configured to generatenegative pressure within lumen 203 of the applicator 204 by air suctionthrough the inlet 235. In some embodiments, housing 206 comprises one ormore openings, for example opening 241 at a surface facing a tissue. Insome embodiments, suction of air through the inlet 235 causespenetration of tissue through the opening 241, optionally firmlyattaching tissue penetrating into lumen 203 against the transducers 208.

According to some exemplary embodiments, the control unit 202 comprisesat least one control circuitry, for example control circuitry 220. Insome embodiments, the control circuitry 220 is electrically connected tomemory 232, which stores indications of values and/or values related toactivation parameters of the system 200. Alternatively or additionally,the memory 232 stored log files of the system. In some embodiments, thememory 232 stores at least one treatment protocol and/or parametersthereof.

According to some exemplary embodiments, the control circuitry 220 iselectrically connected to the one or more transducers 208 of theapplicator 204. In some embodiments, the control circuitry 220 controlsthe activation, for example intermittent and/or alternating activation,of the transducers 208 according to indications stored in memory 232. Insome embodiments, the control circuitry 220 activates two or more or thetransducers 208 in alternation according to a sequence stored in memory232. In some embodiments, the control circuitry activates a transduceror a group of transducers of transducers 208 while other transducers andinactive. In some embodiments, the control circuitry deactivates theactive transducer or the active group of transducers and activates atleast one different ultrasound transducer or a different group oftransducers directed to the same tissue volume.

According to some exemplary embodiments, the control circuitry 220 iselectrically connected to the low-pressure source 237, for example thevacuum pump. In some embodiments, the control circuitry activates thelow-pressure source 237 prior-to activating the transducers 208, forexample to increase the attachment between the tissue and thetransducers 208. In some embodiments, the applicator comprises at leastone pressure sensor, for example pressure sensor 229, electricallyconnected to the control circuitry 220. In some embodiments, thepressure sensor 229 is configured to measure the pressure levels in thelumen 203 of the applicator 204. In some embodiments, the controlcircuitry adjusts the low pressure levels applied by the low pressuresource 237 based on signals received from the pressure sensors 229.Alternatively or additionally, the control circuitry adjusts the lowpressure levels applied by the low pressure source based on indicationsstored in the memory 232.

According to some exemplary embodiments, the applicator 204 comprises atleast one heat sensor, for example heat sensor 228 electricallyconnected to the control circuitry 220. In some embodiments, the heatsensor is a thermistor. In some embodiments, the heat sensor 228 isconfigured to sense the temperature levels of the skin, optionally atthe contact site between the transducers and the tissue. In someembodiments, the control circuitry 220 controls the activation of thecooling system 218, for example the circulation of the cooling liquidbetween the applicator and the cooling system, based on signals receivedfrom the heat sensor 228. In some embodiments, if the temperature of thetissue contacting at least one active transducer is higher than 40° C.,for example higher than 42° C., then the control circuitry 220 increasesthe circulation of the cooling liquid. Alternatively or additionally,the control circuitry 220 signals the TEC to increase the cooling of thetransducers.

According to some exemplary embodiments, the control circuitry 220 iselectrically connected to the transducers 208 and/or to a RF amplifier,for example RF amplifier 223. In some embodiments, if the temperature ofthe tissue contacting at least one active transducer is higher than 40°C., for example higher than 42° C., then the control circuitrydeactivates the at least one active transducer, for example to allowcooling of the tissue. Additionally or optionally, the control circuitryactivates a different transducer or a group of different transducers,for example for continuous heating of the selected tissue volume.

According to some exemplary embodiments, the control unit 202 comprisesat least one user interface, for example user interface 230. In someembodiments, the user interface 230 is configured to generate at leastone human detectable indication, for example a light indication and/or asound indication. In some embodiments, the control circuitry 220 signalsthe user interface 230 to generate an alert signal if the temperaturelevel of the tissue, for example, the tissue contacting the transducersand/or the applicator is higher than a pre-determined value.Alternatively or additionally, the control circuitry 220 signals theuser interface 230 to generate a human detectable indication when atreatment session at a selected tissue target ends.

According to some exemplary embodiments, the user interface 230 isconfigured to receive input from a user of the system 200. In someembodiments, the user input comprises at least one treatment protocol orparameters thereof. Alternatively or additionally, the user inputcomprises vacuum parameters values and/or values of ultrasonic energyparameters, for example intensity and/or frequency values.

According to some exemplary embodiments, the system 200 comprises acover 236. In some embodiments, the cover 236 is shaped and sized toprevent direct contact between the transducers 208 and the tissue,optionally the tissue penetrating through opening 241 into the lumen203. In some embodiments, the cover 236 allows, for example, to maintainsterility of the applicator 204.

According to some exemplary embodiments, the system 200 comprises atissue sensor 221, for example a tissue detection sensor, electricallyconnected to the control circuitry 220. In some embodiments, the tissuedetection sensor is configured to detect tissue type and/or cellularcomposition of the tissue, for example percentage of fat cells in thetissue. In some embodiments, the tissue detection sensor is configuredto detect cellulite. Optionally, the tissue detection sensor detectscellulite by sensing texture changes in the skin, for example by sensingthe presence of dimples in the skin.

According to some exemplary embodiments, the control circuitry 220adjusts the parameter values of ultrasound waves generated by thetransducers 208, for example, frequency and intensity values, accordingto signals received from the tissue sensor 221. In some embodiments, thecontrol circuitry 220 signals the transducers 208 to generate ultrasoundwaves with intensity and frequency values suitable for treatingcellulite, based on signals received from the tissue sensor 221.

Exemplary Spatial Relationship Between Transducers and Tissue Volume

Reference is now made to FIG. 2B depicting a spatial relationship, forexample distance and orientation between one or more ultrasoundtransducers and a tissue volume comprising fat tissue, according to someexemplary embodiments of the invention.

According to some exemplary embodiments, one or more transducers 252 arepositioned at a close contact with a skin layer of a tissue. In someembodiments, the transducers 252 generate ultrasonic waves 258 and 260towards a selected tissue volume, for example tissue volume 262. In someembodiments, the ultrasonic waves 260 and 258 penetrate to a depth of0-30 mm, for example to a depth of 0-20 mm, 15-25 mm, 20-30 mm or anyintermediate, smaller or larger depth, inside the tissue. In someembodiments, the ultrasonic waves penetrate through the dermis layer andinto the selected tissue volume 262, which is positioned in thehypodermis layer comprising a fat tissue layer. In some embodiments, theultrasonic waves are generated with intensity and/or frequency and/orduration sufficient to heat the fat tissue to a temperature in a rangeof 45-85° C., for example to a temperature range of 45-75° C., 52-57°C., 53-85° C. or any intermediate, smaller or larger range oftemperatures. According to some exemplary embodiments, selected tissuevolume 262 in the fat tissue layer is heated to the desired temperaturewhile keeping skin layers, for example the epidermis layer of the skinand optionally the dermis layer cool enough, for example to minimize inat least 50% thermal damage caused by the thermal energy emitted fromthe transducers. In some embodiments, the skin layers are cooled down bya cooling system 250, which cools the skin contacting the transducers,either by cooling the transducers and/or by cooling the skin contactingthe transducers through openings, for example channels passing throughthe transducers. In some embodiments, the channels comprise thermalconductive material configured to conduct cold from the cooling systemdirectly to the skin.

According to some exemplary embodiments, the ultrasound transducers 252are configured to deliver ultrasonic waves to different tissue layers,for example to the lamina propria tissue layer and/or to thefibromuscular tissue layer. In some embodiments, the ultrasoundtransducers 252 deliver ultrasonic waves to the lamina propria and/or tothe fibromuscular in a timed relationship with the delivery ofultrasonic waves to the hypodermis, for example before, after and/orduring the delivery of the ultrasonic waves to the hypodermis. In someembodiments, the ultrasonic waves are delivered to the lamina propriaand/or to the fibromuscular tissue layers as part of additionaltreatment types, for example skin tightening treatments.

Exemplary Treating Different Regions of the Human Body

According to some exemplary embodiments, different regions of the humanbody, for example a male human body and a female human body, are treatedusing ultrasonic energy, for example unfocused ultrasonic energy. Insome embodiments, the ultrasonic energy is delivered as part of bodysculpting or body contouring treatments, which include for example fatreduction. In some embodiments, fat reduction is combined with otherbody contouring treatments. Reference is now made to FIGS. 2C and 2Ddepicting different treatment regions of the human body, according tosome exemplary embodiments of the invention.

According to some exemplary embodiments, the ultrasonic energy isdelivered to one or more body regions or portions thereof of men andwomen comprising, the chin and neck 203, the chest 205, the abdomen 207including abdomen flanks, inner thighs 211, chest sides 219 and 221,outer thighs 215 and 217 and/or the buttocks 213.

According to some exemplary embodiments, for example as shown in FIG.2E, different ultrasound applicators are selected when treatingdifferent regions of the body. In some embodiments, the differentultrasound applicators have different number of ultrasound transducers,different types of ultrasound transducers, for example ultrasoundtransducers having transmitting surface areas with varying size, and/ora different rearrangement of ultrasound transducers. Optionally, some ofthe ultrasound applicators comprise vacuum and/or vibration applicators,for example to apply the ultrasonic energy to the target region in atimed relationship with application of mechanical force on the tissue.In some embodiments, the ultrasound transducers vary in their coolingability, for example when cold is delivered to the tissue before, duringand/or after the application of ultrasonic energy to the tissue.

According to some exemplary embodiments, for example as shown in FIG.2E, an ultrasound applicator, optionally a handheld ultrasoundapplicator for example applicator 213 is used when treated narrow bodyregions and/or small size body regions. In some embodiments, one or moreultrasound applicators, for example ultrasound applicator 215 arepositioned in narrow width regions of the applicator 213, for example toallow positioning of the ultrasound transducer in narrow body regions,for example the neck or the chin. Optionally the handheld ultrasoundapplicator 213 is configured to stretch and/or to vibrate the tissue atthe treatment region before, during and/or after application ofultrasonic energy. In some embodiments, the hand held ultrasoundapplicator 213 or portion thereof, for example a portion containing theone or more ultrasound transducers, is at least partly flexible, forexample to conform to the body contour at the treatment region.

According to some exemplary embodiments, when treating larger regions ofthe human body, for example regions of the abdomen, a belt-shapedultrasound applicator 225 comprises a plurality of ultrasoundtransducers, for example 3, 4, 5, 6 or any larger number of transducers,for example transducers 227, 229 and 231 is used. In some embodiments,the belt-shaped applicator comprises a strap 231, for example an elasticstrap, configured to fasten the ultrasound transducers to the skin atthe treated region. Optionally, the strap 231 interconnects at leastsome of the plurality of transducers. Optionally, the plurality oftransducers are arranged linearly, for example side by side along thetreatment region. Alternatively, the plurality of ultrasound transducersare arranged in any geometrical shape, for example to form a large flatsurface to be placed in contact with the skin at the treatment region,

According to some exemplary embodiments, at least some of the ultrasoundtransducers of the belt-shaped applicator 225 are movable relative toeach other, for example to conform to the contour of the treatmentregion, for example the abdomen. In some embodiments, at least some ofthe ultrasound transducers are interconnected by one or more joints orelastic bands, for example to allow the relative movement of at leastsome of the transducers.

According to some exemplary embodiments, when applying ultrasonic energyto regions of a limb, for example inner or outer parts of a thigh, abelt-shaped applicator 217 is used, for example similar to applicator225, which includes a small number of ultrasound applicators 221 and223. In some embodiments, the number of ultrasound applicators and/ortheir arrangement is adjusted according to the surface area that needsto be treated. In some embodiments, as in applicator 225, the ultrasoundtransducers, for example transducers 221 and 223 are movable relative toeach other, for example to allow the applicator to conform to the shape,for example contour, of the limb. In some embodiments, the ultrasoundapplicator comprises one or more ultrasound applicators within a sleeve,for example a stretchable sleeve. In some embodiments, the sleeve isshaped and sized to allow insertion of a limb of a subject through anopening in the sleeve.

According to some exemplary embodiments, the ultrasound applicators, forexample ultrasound applicators 213, 225 or 217 is electrically connectedto a control unit, for example the control unit 202 shown in FIG. 2A. Insome embodiments, the control unit 202 is used to adjust one or moreparameters of the treatment, for example intensity of the ultrasonicenergy, frequency of the ultrasonic energy, application duration of theultrasonic energy, skin cooling temperature and/or duration or any othertreatment parameter, according to the applicator type and/or treatedbody region.

Exemplary Treatment Process

According to some exemplary embodiments, ultrasonic energy, for exampleunfocused ultrasonic energy is delivered to one or more regions of thehuman body or animal body as part of a treatment, for example a cosmeticfat tissue treatment. In some embodiments, the ultrasonic energy isdelivered with parameter values adjusted to reduce fat in a selected,for example targeted volume in the tissue. In some embodiments, the fatreduction treatment is combined with additional treatments, for exampleskin tightening. In some embodiments, the fat reduction treatment and/orany other treatments using the ultrasonic energy are part of bodysculpting or body contouring treatments. Reference is now made to FIG.2F, depicting a process of delivery of one or more treatment types,according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example during a diagnosingmeeting, a treatment region is identified at block 251. In someembodiments, the identified treatment region comprises one or more ofchin, neck, chest, abdomen, abdomen flanks, inner thighs, outer thighs,chest sides and/or the buttocks.

According to some exemplary embodiments, the identified treatment regionis characterized at block 253. In some embodiments, the identifiedtreatment region is characterized, for example by identifying one ormore of cell types, tissue layer types, order of the tissue layers,thickness of one or more of the tissue layers, size and/or shape of oneor more of the tissue layers in the treatment target.

According to some exemplary embodiments, optionally, treatment typeapplications are selected at block 255. In some embodiments, one or moretreatment application types are selected at block 255. In someembodiments, the one or more treatment type applications are selectedaccording to the treatment region identified for example at block 251,and/or based on the characteristics of the treatment region. In someembodiments, the treatment types comprise in addition to fat reductiontreatments used for example to change the shape and size of fat cells,skin tightening treatments, and/or cellulite reduction treatments forexample by shrinking and/or remodeling connective tissue.

According to some exemplary embodiments, subject suitability to theselected one or more treatment applications is determined at block 257.In some embodiments, the subject suitability to the selected one or moretreatment applications is determined based on one or more of, subjectcurrent clinical condition, subject medical history, subject drugregime, subject thermal sensitivity for example the sensitivity of thesubject to high levels of heat and/or cold, and/or subject age.

According to some exemplary embodiments, an ultrasound applicator isselected at block 258. In some embodiments, an ultrasound applicator isselected according to the selected one or more treatment applicationstype and/or according to the identified target region. In someembodiments, if the identified target region comprises the chin or theneck, for example as shown in FIG. 2C, then the selected application ina hand held ultrasound applicator that is, for example, at least partlyflexible. Optionally, the applicator for treating the chin and/or theneck regions comprises one or more ultrasound transducers located on anarrow width portion of the applicator body, for example applicator 213shown in FIG. 2E. In some embodiments, the hand held applicator 213 isused to treat body regions that have a surface area size of up to 400cm², for example up to 200 cm², up to 300 cm², up to 400 cm², or anyintermediate, smaller or larger surface area size.

According to some exemplary embodiments, if he selected treatment regioncomprises one or more treatment regions that have a large surface area,for example the abdomen, the chest and/or the buttocks, the selectedultrasound applicator comprises an array of ultrasound transducerscoupled to each other and arranged to deliver ultrasonic energy to alarge surface area, for example surface areas up to 1500 cm², forexample up to 800 cm², up to 1000 cm², up to 1200 cm² or anyintermediate, smaller or larger surface area size.

According to some exemplary embodiments, treatment parameter values areadjusted at block 259. In some embodiments, the treatment parameters areadjusted according to properties of the tissue layers at the identifiedtreatment target, for example thickness, size, shape, depth of fat cellsor fat layer from the epithelium or from the external layer of the skin,the shape, size and/or width of the fat layer. In some embodiments, thetreatment parameters are adjusted according to the presence of nerve,blood vessels and/or other organs, for example organs that should notreceive the ultrasonic energy, in the target region or near the targetregion, for example up to 5 cm, up to 4 cm, up to 2 cm or anyintermediate, smaller or larger value from the target region.

According to some exemplary embodiments, treatment parameter values areadjusted according to characteristics of the subject, for example thesubject ability to sustain continuous high heat levels or high coldlevels during a predetermined time period, for example a time period ina range of 2-180 seconds, for example 2-50 seconds, 40-100 seconds,50-120 seconds, 70-180 seconds, or any intermediate, smaller or largerrange of values. In some embodiments, the treatment parameters comprise,ultrasonic waves frequency, ultrasonic waves intensity, duration ofultrasonic waves delivery, angle of delivery, cold level delivered tothe skin and/or the duration of cold delivery. In some embodiments, thetreatment parameters are adjusted according to the selected applicatorand/or the characteristics of the treatment region.

According to some exemplary embodiments, when hating a fat cells layer,two or more ultrasound transducers of an applicator are directed to thesame target region and are activated intermittently, for example toreduce epithelium heating by a single ultrasound transducer at aspecific location, while continuously heating the fat cells layer by adifferent ultrasound transducer. In some embodiments, cold iscontinuously delivered to the epithelium by the two or more ultrasoundtransducers that deliver ultrasonic energy intermittently.Alternatively, cold is delivered intermittently by the two or moretransducers. In some embodiments, the adjuster treatment parameterscomprises the activation duration and/or sequence of activation of thetwo or more intermittently activated ultrasound transducers.

According to some exemplary embodiments, optionally, a drug isadministered, for example systemically, or applied, for example,topically applied at block 261. In some embodiments, the drug is used toreduce thermal sensitivity of a subject or a specific skin region tohigh levels of heat and/or cold. In some embodiments, the drug is atopical anesthetic drug. In some embodiments, the drug comprisesLidocaine, prilocaine or any combination thereof.

According to some exemplary embodiments, a treatment, for example acosmetic treatment to treat fat is delivered at block 263. In someembodiments, the treatment is delivered using the treatment parametervalues adjusted at block 259. In some embodiments, the treatment isdelivered to the to the identified treatment region.

According to some exemplary embodiments, optionally, treatment sideeffects are evaluated at block 265. In some embodiments, the treatmentside effects are evaluated during the delivery of the ultrasonic energyto the fat tissue layer. Alternatively or additionally, the treatmentside effects are evaluated after the delivery of the ultrasonic energyis stopped, for example up to 30 seconds, up to 1 minute, up to 10minutes, up to 1 hour, up to 1 day or any intermediate, shorter orlonger time period following the stopping of ultrasonic energy delivery.In some embodiments, the treatment side effects comprise the formationof edema at or near a contact site of the ultrasound transducers withthe skin. Additionally or alternatively, the treatment side effectscomprise formation of skin erythema or skin redness at or near a contactsite of the ultrasound transducers with the skin. In some embodiments,the side effects comprise complaints of the treated subject on painsensation.

According to some exemplary embodiments, the side effects are evaluatedwhile the subject is in the clinic following a treatment session inwhich ultrasonic energy is delivered to the tissue. As used herein, aclinic refers to any location other than the house of the subject inwhich treatment and/or evaluation is provided. In some embodiments, theside effects are evaluated between two or more consecutive treatmentsessions, scheduled for the save visit. Alternatively, the side effectsare evaluated between visits, for example when the subject is at home.Optionally, the side effects are evaluated at home by the subjecthimself, for example, using an optic sensor of a mobile device, forexample a cellular device. In some embodiments, the side effects areevaluated in a new visit at the clinic, for example in the beginning ofa new treatment session.

According to some exemplary embodiments, a treatment effect is evaluatedat block 267. In some embodiments, evaluation of the treatment effectcomprises evaluation of the skin, for example evaluation of the shapeand color of the skin. In some embodiments, evaluation of the treatmenteffect comprises evaluating shape and/or appearance of the treatmenttarget, for example circumference of the treatment target.

According to some exemplary embodiments, the treatment effect isevaluated while the subject is in a visit following a treatment sessionor between two or more consecutive treatment sessions scheduled for thesame visit in the clinic. In some embodiments, the treatment effect isevaluated at least 5 minutes, for example at least 10 minutes, at least15 minutes, at least 30 minutes or any intermediate, shorter or longertime period following a treatment session, while the subject is still inthe clinic. Alternatively or additionally, the treatment effect isevaluated at least 30 minutes, at least 1 hour, at least 24 hours, atleast 48 hours or any intermediate, shorter or longer time periodfollowing a treatment session while the subject is at home. Optionally,the subject evaluated the treatment effect at home using an optic sensorof a mobile device, for example a cellular device.

According to some exemplary embodiments, if the treatment effect is nota desired effect, then the treatment is delivered again, in one or moretreatment sessions at block 263. In some embodiments, the treatment isdelivered again in one or more visits to the clinic. In someembodiments, if the treatment effect is not a desired effect then, thetreatment is stopped at block 269. In some embodiments, if side effectsappear, for example in an extent that is not allowed by the treatmentprotocol and/or regulatory approval, the treatment is stopped at block269.

According to some exemplary embodiments, if the treatment effect is nota desired effect, then the ultrasound applicator is optionally changedat block 271. In some embodiments, the ultrasound applicator is changed,for example to better fit a selected treatment application and/or anidentified treatment region. In some embodiments, the ultrasoundapplicator is changed to an ultrasound applicator which includes adifferent number of ultrasound transducers and/or a differentarrangement of ultrasound transducers. In some embodiments, if sideeffects appear, for example in an extent that is not allowed by thetreatment protocol and/or regulatory approval, the ultrasound applicatoris changed at block 271.

According to some exemplary embodiments, if the treatment effect is nota desired effect, then the treatment parameters are modified at block273. In some embodiments, the treatment parameters are modified at block273 if side effects appear, for example in an extent that is not allowedby the treatment protocol and/or regulatory approval. In someembodiments, the treatment parameters are modified, for exampleultrasound waves frequency, intensity, delivery time, coolingtemperature and/or cooling direction.

According to some exemplary embodiments, if the treatment effect is adesired effect, then a treatment application is switched to a differentapplication at block 275. In some embodiments, if the fat tissuereduction treatment reaches a desired effect, then the treatmentapplication is switched to a skin tightening treatment applicationand/or other skin treatments.

Reference is now made to FIG. 2G, depicting a treatment scheme,according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a subject arrives to atreatment center, for example a clinic to a pre-treatment visit at block277. In some embodiments, the pre-treatment visit comprises performingone or more of identification of a treatment region, characterization ofthe treatment region, selection of treatment application types, andsubject suitability determination, for example as described in steps251-257 shown in FIG. 2F. In some embodiments, during the pre-treatmentvisit, a treatment plan is prepared. In some embodiments, the treatmentplan comprises one or more of number of visits, number of treatmentsessions per visit, time duration between visits, number of evaluationvisits, type of evaluation, for example evaluation in the clinic orevaluation at home, amount of overall energy to be delivered to thetissue, amount of energy to be delivered to the tissue is a single visitand/or in a single treatment session.

According to some exemplary embodiments, the subject arrives at theclinic for a treatment visit 279, for example to receive ultrasonicenergy treatment. In some embodiments, each treatment visit to theclinic lasts a time duration of up to 3 hours, for example up to 2hours, up to 1 hour, up to 0.5 hour, up to 0.25 hour or anyintermediate, smaller or larger time duration. In some embodiments, eachtreatment visit, for example treatment visit 279, comprises one or moretreatment sessions, for example treatment sessions 281 in whichultrasonic energy is actively delivered to the tissue, for example asdescribed in block 263 shown in FIG. 2F. Additionally, each treatmentvisit, for example treatment visit 279 comprises at least one evaluationsession, for example evaluation sessions 283. In some embodiments, theat least one evaluation session comprises evaluation of side effects,for example as described in block 265 shown in FIG. 2F, and/orevaluation of a treatment effect, for example as described in block 267shown in FIG. 2F. In some embodiments, at an end of a treatment visit,the subject is released from the clinic to his home.

According to some exemplary embodiments, optionally, the subject arrivesat the clinic to a follow up visit, for example an evaluation visit, atblock 285. In some embodiments, the evaluation visit is scheduled atleast 1 day, for example 1 day, 3 days, 1 week, 2 weeks, 1 month, 3months or any intermediate, shorter or longer time period following atreatment visit, for example treatment visit 279. In some embodiments,the evaluation visit comprises evaluation of side effects, for exampleas described at block 265 shown in FIG. 2F, and/or evaluation of atreatment effect, for example as described at block 267 shown in FIG.2F.

According to some exemplary embodiments, optionally, the subjectundergoes home evaluation at block 287. In some embodiments, the subjectundergoes home evaluation using one or more sensors, for example anoptic sensor of a mobile device, for example a cellular device.Optionally, the home evaluation is performed using a designatedapplication installed in a memory of the mobile device. In someembodiments, the home evaluation comprises evaluation of side effects,for example as described at block 265 shown in FIG. 2F, and/orevaluation of a treatment effect, for example as described at block 267shown in FIG. 2F. In some embodiments, the home evaluation is scheduledat least 1 day, for example 1 day, 3 days, 1 week, 2 weeks, 1 month, 3months or any intermediate, shorter or longer time period following atreatment visit, for example treatment visit 279. Optionally, thesubject receives an alert signal from the mobile device to perform thehome evaluation.

According to some exemplary embodiments, based on the results of theevaluation visit at block 285 and/or the home evaluation at block 287,additional treatment visits are scheduled at block 289 and/or additionalevaluation visits or home evaluations are scheduled at blocks 291 and293 respectively.

Exemplary Detailed Fat Tissue Treatment Process

Reference is now made to FIG. 3A depicting a detailed process fortreating fat tissue, according to some exemplary embodiments of theinvention.

According to some exemplary embodiments, a treatment target is selectedat 302. In some embodiments, the treatment target comprises a tissueregion which is accessible to an ultrasound applicator. In someembodiments, the treatment target is selected based on a distancebetween the skin and selected tissue volume located within the tissue atthe treatment target.

According to some exemplary embodiments, a treatment protocol isselected at 304. In some embodiments, the treatment protocol is selectedbased on an anatomical location of the selected treatment target.Alternatively or additionally, the treatment protocol is selected basedon the age and/or the gender of the subject. Optionally, the treatmentprotocol is selected based on the tissue composition in the selectedtreatment target and/or the selected tissue composition in the selectedtissue volume. In some embodiments, the tissue composition comprises aratio between fat cells and other tissue types, for example collagenand/or elastin fibers, blood vessels, fibroblasts and so, in theselected tissue volume.

According to some exemplary embodiments, vacuum parameter values areadjusted at 306. In some embodiments, the vacuum parameter values areadjusted based on an anatomical location of the selected treatmenttarget. Alternatively or additionally, the vacuum parameter values areadjusted, based on the tissue composition in the selected treatmenttarget and/or the selected tissue composition in the selected tissuevolume. In some embodiments, the vacuum parameter values are adjustedbased on the elasticity of the tissue, for example based on the abilityof the tissue to bend and/or to stretch.

According to some exemplary embodiments, an angle between thetransducers and a target tissue volume is adjusted at 308. In someembodiments, at least some of transducers are positioned on a movablesurface that allows to align the transducers at a desired angle with aselected tissue volume, for example to generate a selective effect atthe tissue volume and not at adjacent tissue regions.

According to some exemplary embodiments, vacuum is applied at 310. Insome embodiments, vacuum is applied on the tissue, for example byactivating the low-pressure source 237 shown in FIG. 2A. In someembodiments, vacuum application causes at least part of the tissue tobend through at least one opening of the ultrasound applicator. In someembodiments, bending of the tissue through the opening presses thetissue against one or more ultrasound transducers of the ultrasoundapplicator.

According to some exemplary embodiments, ultrasonic energy is deliveredto the selected tissue volume at 312. In some embodiments, theultrasonic energy is generated by one or more transducers, for exampletransducers 208 shown in FIG. 2A. According to some exemplaryembodiments, tissue contacting the transducers is cooled at 314. In someembodiments, the contacting tissue is cooled during the generation ofthe ultrasonic energy. Alternatively or additionally, the contactingtissue is cooled as long the tissue remains in contact with the at leastpart of the external surface of the one or more transducers. In someembodiments, the contacting tissue is cooled by cooling elements passingthrough a transducer body, for example through channels in thetransducer body.

According to some exemplary embodiments, different transducers areactivated at 316. In some embodiments, a least some of the transducersare sequentially activated, for example transducer groups directed tothe same tissue volume are activated sequentially. Alternatively, singletransducers are activated sequentially. In some embodiments, thetransducers are sequentially activated for example, to allow continuousheating of the selected tissue volume without causing thermal damage tothe skin be heating a single skin area.

According to some exemplary embodiments, the delivery of ultrasonicenergy is stopped at 318. In some embodiments, the delivery ofultrasonic energy is stopped when a treatment session is finished.Alternatively, the delivery of ultrasonic energy is stopped when a skintemperature at a contact point between the transducers and/or theapplicator reaches a pre-determined temperature value, for example 42°C.

Exemplary Ultrasound Applicator

Reference is now made to FIG. 3B, depicting an ultrasound applicatorfrom a bottom view, according to some exemplary embodiments of theinvention.

According to some exemplary embodiments, ultrasound applicator, forexample applicator 320 comprises at least one cooling chamber, forexample cooling chamber 322. Optionally, the cooling chamber is acentral cooling chamber and is used to cool a plurality of coolingelements, for example a plurality of TECs. In some embodiments, thecooling chamber is a ring shaped cooling chamber, shaped and sized tosurround an inner lumen of the applicator 320. In some embodiments, theapplicator 320 comprises housing 321 having at least one opening througha surface of said housing, for example opening 350, connecting the innerlumen with the external environment.

According to some exemplary embodiments, the applicator 320 comprisesone or more cooling elements for example one or more TECs. In someembodiments, the applicator, for example applicator 320 comprises atleast two TECs, for example 2 TECs, 4 TECs, 6 TECs or any intermediate,smaller or larger number of TECs. In some embodiments, for example asshown in FIG. 3B the applicator 320 comprises 4 TECs, for example TECs324, 326, 328, and 330. In some embodiments, a hot surface of each TECis attached to a surface of the cooling chamber 322, for example toallow heat dissipation from the TEC to the cooling liquid inside thecooling chamber 322.

According to some exemplary embodiments, a cold surface of each TEC isattached directly to an ultrasound transducer, for example to cool downthe ultrasound transducer. Alternatively, the cold surface of the TEC isattached to transducer holder, for example a transducer base. In someembodiments, the transducer holder is a thermal conductive transducerholder, optionally made from Aluminum. In some embodiments, for exampleas shown in FIG. 3B, each of the TECs 324, 326, 328 and 330 is attachedto a single transducer, for example transducers 340, 344, 342 and 346respectively.

According to some exemplary embodiments, each of the transducers isaligned to face at least partly the inner lumen of the applicator and/orthe opening 350. In some embodiments, each of the transducers is alignedto have an ultrasound emitting surface of the transducer facing at leastpartly the inner lumen of the applicator and/or the opening 350. In someembodiments, the transducers are aligned by an angled portion of eachtransducer base which is shaped and sized to align the transducerstowards the inner lumen or the opening 350. In some embodiments, thetransducers surround the inner lumen and/or the opening 350. In someembodiments, the transducers are evenly spaced-apart around the opening350. Optionally, at least two transducers face each other, for exampletransducers 340 and 344, and transducers 342 and 346. In someembodiments, at least two transducers are positioned in oppositedirections around the opening 350.

According to some exemplary embodiments, the applicator 320 comprises anopening of a low-pressure source, for example a vacuum opening 352 alsotermed herein in some embodiments as vacuum outlet. In some embodiments,activation of a low-pressure source, for example a vacuum pump,connected to the vacuum opening 352, lowers the pressure within theinner lumen of the applicator 320. Optionally, lowering the pressurecauses a tissue contacting the applicator to penetrate at least partlyinto the inner lumen through the opening 350.

According to some exemplary embodiments, the applicator comprises atleast one cover, for example cover 350. In some embodiments, cover 50covers the transducers when they are placed in contact with tissue, forexample to maintain sterility of the transducers and/or at least part ofthe applicator.

Reference is now made to FIG. 4A depicting a cross-section of anultrasound applicator with at least two ultrasound transducers directedtowards a single tissue volume, according to some exemplary embodimentsof the invention.

According to some exemplary embodiments, an ultrasound applicator, forexample applicator 402 comprises casing 404 and at least one opening inthe casing 404, for example opening 416. In some embodiments, theapplicator 402 comprises at least one cooling chamber, for examplecooling chamber 406. In some embodiments, the cooling chamber 406surrounds an internal lumen of the applicator 402, for example lumen419. In some embodiments, the cooling chamber comprises cooling liquid,for example water, which circulates between the applicator 402 and acooling system in a control unit, for example as described in FIG. 2A.

According to some exemplary embodiments, a lower surface of the coolingbath is attached to a surface of an adaptor, for example adaptor 408. Insome embodiments, the adaptor 408 is a thermal conducting adaptor,optionally made from Aluminum. In some embodiments, the adaptor 408 isan angled adaptor, having a lower surface positioned in an anglerelative to the upper surface contacting the cooling chamber. In someembodiments, the applicator comprises a plurality of adaptors attachedto the lower surface of the cooling bath. Additionally, the plurality ofadaptors surround the lumen 419 of the applicator 402.

According to some exemplary embodiments, at least one cooling element,for example TEC 409 is attached to a lower surface of adaptor 408. Insome embodiments, each adaptor is attached to one or more TECs.Optionally, each adaptor is attached to a single TEC. In someembodiments, a lower surface of adaptor 408 is attached to a hot surfaceof TEC 409, and a lower surface of adaptor 407 is attached to a hotsurface of adaptor 410.

According to some exemplary embodiments, each TEC is connected to atleast one ultrasound transducer by a transducer holder. In someembodiments, a cold surface of the TEC is attached to an upper surfaceof the transducer holder or directly to the ultrasound transducer. Insome embodiments, the cold surface of the TEC cools the transducerand/or a tissue contacting the transducer via the transducer holder orby directly contacting the transducer. In some embodiments, a coldsurface of TEC 409 is connected to an ultrasound transducer 415 by atransducer holder 413. Additionally, a cold surface of TEC 410 isconnected to an ultrasound transducer 414 by a transducer holder 412.

According to some exemplary embodiments, each of the transducers of asingle applicator, for example transducers 414 and 415 face the opening416 in the applicator's casing. Optionally, each of the transducers of asingle applicator at least partly faces at least some of the othertransducers of the same applicator.

According to some exemplary embodiments, the applicator 402 comprises atleast one vacuum outlet, for example outlet 420 in the applicator innerlumen, for example lumen 419. In some embodiments, the outlet 420 isconnected to a low-pressure source, optionally positioned in a controlunit connected to the applicator, for example as described in FIG. 2A.

Reference is now made to FIG. 4B which is a cross section view,depicting the applicator shown in FIG. 4A during the delivery ofultrasonic energy to a tissue volume, according to some exemplaryembodiments of the invention.

According to some exemplary embodiments, vacuum is applied through theoutlet 420 causing suction of air into the outlet in direction 403 andreduces the pressure within the inner lumen 419. In some embodiments,application of vacuum while pressing the applicator against a tissuesurface causes penetration of tissue 421 through the opening 416 atleast partly into the lumen 419. In some embodiments, at least partialpenetration of the tissue 421 into the lumen 419 forces the tissueagainst the transducers 414 and 415, optionally ensuring tight contactbetween the transducers and the skin when delivering the ultrasonicenergy.

According to some exemplary embodiments, while vacuum is applied, eachtransducer generates ultrasonic waves, for example unfocused ultrasonicwaves, for example beams 422 and 424, from different angular directionsinto a single tissue volume 426. In some embodiments, the applicator isconfigured to deliver ultrasonic waves to a tissue volume in a range of10-10000 mm{circumflex over ( )}2, for example 10-800 mm{circumflex over( )}2, 20-1000 mm{circumflex over ( )}2, 900-5000 mm{circumflex over( )}2, 4000-10,000 mm{circumflex over ( )}2 or any intermediate, smalleror larger tissue volume. In some embodiments, each of the transducers ofa single ultrasound applicator is positioned in an angle of 0-90°,relative to the tissue volume, for example in an angle of 10°, 20°, 30°,45° or any intermediate, smaller or larger value. In some embodiments,treated tissue volumes are separated by regions of tissue with nodamage. In some embodiments, the distance between treated tissue volumesis in the range of 0.5-20 mm, for example in a range of 1-15 mm, 1-5 mm,4-20 mm or any intermediate, smaller or larger range of values.

Reference is now made to FIGS. 5A and 5B depicting a cross-section viewof an applicator where the ultrasound transducers are directed to asmaller tissue volume, according to some exemplary embodiments of theinvention.

According to some exemplary embodiments, replacing an adaptor betweenthe cooling bath and the TEC allows, for example to change the relativeangle between the transducers of an ultrasound applicator and a tissuevolume. In some embodiments, for example as shown in FIG. 5A, adaptors507 and 508 are attached to the cooling chamber 506. In someembodiments, a lower surface of each of the adaptors is positioned in alarger angle 513 relative to the cooling chamber and/or to the uppersurface of the adaptor, compared to angle 411 in applicator 402.

According to some exemplary embodiments, for example as shown in FIG.5B, when vacuum is applied in lumen 519 of the applicator 502, a tissueportion 521 penetrated through an opening 516 into an inner lumen 519 ofthe applicator. In some embodiments, ultrasonic waves generated bytransducers 514 and 515, for example beams 524 and 522 respectively aredirected to a smaller tissue volume 526. In some embodiments, theultrasonic waves penetrate through a dermis layer 501 of the skin andinto the tissue volume 526 in a hypodermis layer 503 containing fattissue, for example as previously shown in FIG. 2B. In some embodiments,the ultrasonic waves are generated with frequency and/or intensityvalues that prevent at least partly the penetration of the ultrasonicwaves into a muscle tissue layer 505 located underneath the hypodermislayer 503.

According to some exemplary embodiments, an angle between thetransducers and the tissue volume is controlled using one or more angledadaptors between the cooling chamber and the transducers. Optionally,the adaptors are flexible and optionally allow to control the angle bycontrolling the applied vacuum level. In some embodiments, high vacuumlevels cause the adaptors to bend inward, and to direct the ultrasonicwaves to a smaller tissue volume.

Reference is now made to FIGS. 6A and 6B depicting a cross-section viewof an ultrasound applicator having a large contact area between a TECand a cooling chamber, according to some exemplary embodiments of theinvention.

According to some exemplary embodiments, an ultrasound applicator, forexample applicator 602 comprises a housing 604 having at least opening616 shaped and sized to face a tissue. In some embodiments, theapplicator 602 comprises at least one cooling chamber, for examplecooling chamber 606. In some embodiments, the cooling chamber 606comprises cooling liquid, for example water, as previously described inFIG. 5A. In some embodiments, the cooling chamber 606 surrounds an innerlumen 619.

According to some exemplary embodiments, a side surface of the coolingchamber 606 is attached to at two or more cooling elements, for exampleTECs 610 and 611. In some embodiments, a hot surface of each of the TECsis attached to the surface of the cooling chamber 606, for example toallow heat dissipation from the TEC into the cooling liquid inside thecooling chamber.

According to some exemplary embodiments, a cold surface of the TEC, forexample TEC 610 is attached to a surface of at least one transducerholder, for example transducer holder 612. In some embodiments, thetransducer holder 612 is a thermally conductive transducer holder,configured to conduct cold towards at least one ultrasound transducer,for example transducer 612 attached to the holder. In some embodiments,the transducer holder is made from a thermally conductive material, forexample aluminum.

According to some exemplary embodiments, a distal section of eachtransducer holder, for example distal section 617 is angled towards theopening 616 and/or the inner lumen 619. In some embodiments, thetransducer 615 is attached to a distal end of the transducer holder 617.

According to some exemplary embodiments, at least one vacuum outlet, forexample outlet 620 is connected to the inner lumen 619. In someembodiments, activation of a low-pressure source connected to the outlet620 allows lower the pressure levels within the inner lumen 619.

According to some exemplary embodiments, for example as shown in FIG.6B, lowering the pressure levels in the inner lumen 619 while theapplicator is attached to a tissue surface causes a partial penetrationof a tissue portion 621 through the opening 616 into the inner lumen 619of the applicator. In some embodiments, the partial penetration of thetissue portion 621 into the inner lumen 619 pushes the tissue againstthe transducers, for example transducers 614 and 615. In someembodiments, ultrasonic waves generated by the transducers 614 and 615are directed towards the same tissue volume, for example tissue volume626.

A potential advantage of having a large contact area, and optionally adirect contact between a hot surface of a TEC and a surface of a coolingchamber is that it improves heat dissipation and allows to activateultrasound transducers with large contact area with the skin, for longertime periods.

Exemplary Ultrasound Applicators Array

According to some exemplary embodiments, a two or more ultrasoundapplicators are combined into an array of ultrasound applicators. Insome embodiments, an ultrasound applicator array is used, for example totreat large areas of tissue, which optionally include fat tissue.Reference is now made to FIG. 6C depicting an array of ultrasoundapplicators, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, an array of ultrasoundapplicators, for example array 660 comprises two or more ultrasoundapplicators, for example applicator 320 previously shown in FIG. 3B. Insome embodiments, the two or more transducers are attached to an elasticmaterial, for example a strap or a belt. In some embodiments, theelastic material is shaped and sized to be wrapped around a body part,for example a limb. In some embodiments, the array is fastened to atissue surface and/or a body part by one or more fasteners.

Exemplary Ultrasound Transducer with One or More Openings

Reference is now made to FIG. 7A, depicting an ultrasound transducerwith at least one channel, according to some exemplary embodiments ofthe invention.

According to some exemplary embodiments, an ultrasound transducercomprises a PZT plate, for example plate 702 with one or more channels,for example channel 704 and channel 706. In some embodiments, thechannels cross-through the plate from a first surface to a secondsurface of the plate 702.

Reference is now made to FIGS. 7B-7E depicting different assemblies ofan ultrasound transducer having at least one channel, according to someexemplary embodiments of the invention.

According to some exemplary embodiments, assembly 710 comprises acooling basement 712, for example a transducer holder, attached to anupper surface PZT plate 702. In some embodiments, the assembly 710comprises a flex PCB 716, attached to a lower surface of the PZT plate702. In some embodiments, one or more temperature sensors, for examplethermistor 714, are electrically connected to the flex PCB 716 and arepositioned within the channels, for example within channel 704 of thePZT plate 702. Optionally, each thermistor is positioned in a differentchannel.

According to some exemplary embodiments, having a PZT plate with emptychannels allows, for example to cool a tissue contacting the flex PCB,through the channels. In some embodiments, the thermistors in thechannels allow, for example, to monitor the temperature level of the PZTplate during the delivery of ultrasonic energy, and or the temperatureinside the channel, for example to determine the efficiency level of thecooling process. Additionally or alternatively, the thermistors monitorthe temperature at the contact point between the PZT plate and thecontacting tissue.

According to some exemplary embodiments, for example as shown in FIG.7C, a cooling basement 721 is attached to a surface of a PZT plate 702having one or more channels, for example channels 704 and 706 shown inFIGS. 7A and 7B. In some embodiments, each channel is filled with athermal conductive material, forming cooling basement pillars, forexample thermal-conductive pillars 724 attached or part of a coolingbasement 721. In some embodiments, filling the channels with thermalconducting materials, for example to form thermal conducting pillars,allows, a more efficient cooling of a tissue contacting the PZT platecompared to an assembly with empty pillars.

According to some exemplary embodiments, for example as shown in FIG.7D, in assembly 730 at least some the channels crossing through the PZTplate 702 comprise a lower thermal conductivity material 733, betweenthe thermal conductive pillars 724 and the flex PCB. In someembodiments, having less efficient thermal conductive material betweenthe pillars 724 and the flex PCB which is placed in contact with thetissue allows, for example, to prevent over-cooling of the tissue. Insome embodiments, for example as shown in FIG. 7E, the assembly 730comprises one or more thermistors, for example thermistors 735 attachedto the PCB. In some embodiments, the thermistors 735 are positionedwithin the channels of the PZT plate 702, optionally at least onethermistor per channel. In some embodiments, the thermistors arepositioned near the contact of the flex PCB 736 with the tissue.Alternatively or additionally, the thermistors 735 are positioned withinor near the lower thermal conductivity material 733. In someembodiments, the thermistors in the channels allow, for example, tomonitor the temperature level of the PZT plate during the delivery ofultrasonic energy, and or to measure the temperature inside the channel,for example to determine the efficiency level of the cooling process.Additionally or alternatively, the thermistors monitor the temperatureat the contact point between the PZT plate and the contacting tissue.

Exemplary Fat Layer Targeting

According to some exemplary embodiments, tissue at a selected anatomicallocation is analysed, for example to identify the fat layer, for examplethe hypodermis. In some embodiments, once the fat tissue layer isidentified, treatment parameters are adjusted in order to target aselected tissue volume within the fat layer, optionally without causingdamage to other tissue layers and/or organs near the selected tissuevolume and/or near the fat tissue layer. Reference is now made to FIG.7F depicting a schematic cross-section of different tissue layers of theskin, and FIG. 7G depicting a process for targeting fat tissue layeraccording to some exemplary embodiments of the invention.

According to some exemplary embodiments, a fat tissue layer isidentified at block 764. In some embodiments, the fat tissue layer isidentified by positioning a tissue scanner or a tissue sensor at aselected target location. In some embodiments, for example as shown inFIG. 7F, a scanner, for example an ultrasound scanner 740 is positionedat a selected target location on the skin, for example location 742. Insome embodiments, the ultrasound scanner 740 is used to scan the tissuelayers at the selected target location. In some embodiments, the scanner740 is used to identify the fat tissue layer 748. Optionally, thescanner 740 is activated at an A-MODE, for example to identify the fattissue layer 748.

According to some exemplary embodiments, boundaries of the fat tissuelayer 748 are determined at block 766, for example using the scanner740. In some embodiments, a border or an interface region between thefat tissue layer 748 and the dermis layer 750 is determined, for exampleusing the scanner 740. Alternatively or additionally, a border or aninterface region between the fat tissue layer 748 and the muscle layer754 is determined, for example using the scanner 740. In someembodiments, a depth of the fat tissue layer 748 from the scanner or theexternal layer of the skin is calculated. In some embodiments, a widthof the fat tissue layer 748 is calculated.

According to some exemplary embodiments, for example as shown in FIG.7F, the fat tissue layer 748 is located at different depths from theepithelium layer, depending on a location of the external surface of theskin. In some embodiments, in location 742 on the external surface ofthe skin, the fat layer 748 is located at a larger depth from theepithelium, compared to the depth of the fat layer 748 from theepithelium in location 756. In some embodiments, a scanner 740 placed onthe external surface of the skin, for example at a target location 742identifies the fat tissue layer 748, and/or the border 744 of the fattissue layer 748 with the dermis 750 and/or the border 752 of the fattissue layer 748 with the muscle layer 754. Optionally, based on theborders detection, a width of the fat tissue layer at target location742 is calculated.

According to some exemplary embodiments, when moving on the externalsurface of the skin to a different target location, for example targetlocation 756, a depth of the fat tissue layer 748 from the epitheliumchanges. In some embodiments, a border 760 between the fat tissue layer748 and the dermis 750 is located at a different depth relative to theborder 746. In some embodiments, the border 762 between the fat tissuelayer 748 and the muscle layer 754 is located at a different depthrelative to the border 752. Optionally a width of the fat tissue layer748 at location 756 is different from a width of the fat tissue layer atlocation 742.

According to some exemplary embodiments, a position of selected one ormore target volumes, for example target volumes 744 and 758 in the fattissue layer 748, is identified. In some embodiments, the depth of theone or more target volumes from the epithelium or any other referencepoint, is calculated.

According to some exemplary embodiments, one or more treatmentparameters are adjusted according to the identified position of the fattissue layer and/or determined borders of the fat tissue layer, at block768. In some embodiments, one or more treatment parameters are adjustedat block 768, for example according to the identified position of one ormore target volumes in the fat tissue layer. In some embodiments, one ormore treatment parameters are adjusted according to a depth of the fattissue layer from the epithelium layer or any other reference point,and/or a width of the fat tissue layer. In some embodiments, thetreatment parameters comprise one or more of frequency of ultrasonicwaves, intensity of ultrasonic waves, angle of one or more ultrasoundtransducers relative to a selected target volume.

According to some exemplary embodiments, the one or more treatmentparameters are adjusted according to regulatory and/or safetylimitations. In some embodiments, the one or more treatment parametersare changed automatically, for example by entering a name or coordinatesof a selected location on the skin to a control unit, for example acontrol console of the applicator. In some embodiments, a memory of acontrol unit, for example memory 232 shown in FIG. 2A, stores one ormore treatment parameter values or indications thereof, related toselected one or more anatomical locations or coordinates on the externalsurface of the skin.

According to some exemplary embodiments, the one or more treatmentparameters are adjusted manually, for example following a scan of tissuelayers, using one or more scanners, for example scanner 740. In someembodiments, a position sensor, a tissue sensor or any type of sensor inthe ultrasound applicator used to deliver the ultrasound treatment, isused to identify the fat tissue layer, the borders with adjacent tissuelayers, the depth of the fat tissue later from the skin surface and/or awidth of the fat tissue layer at a selected location on the skinsurface.

Exemplary Cellulite Treatment

According to some exemplary embodiments, ultrasonic waves, for exampleunfocused ultrasonic waves, are used to treat cellulite. Reference isnow made to FIG. 7H, depicting a schematic cross-section view of tissuelayers at a cellulite-affected area of the body, according to someexemplary embodiments of the invention.

According to some exemplary embodiments, an ultrasound applicator, forexample, applicator 776 is positioned on an external surface of theskin. In some embodiments, the applicator 776 delivers ultrasonic energyto different layers of the skin, for example to treat cellulite. In someembodiments, one or more of the cellulite treatment parameters areadjusted, for example to deliver ultrasonic energy, for exampleunfocused ultrasonic energy to different tissue layers. In someembodiments, the tissue layers comprise one or more of the layers, theepidermis comprising cells 778, the dermis which includes dermis cells780, fat tissue layer which includes fat cells 782, optionally organizedin clusters, and connective tissue 784 optionally located betweenadjacent fat cells clusters in the fat tissue layer, blood vessels 786which deliver blood to the fat cells 782, a reserve fat layer whichincludes fat cells 788, and a muscle layer which includes muscle cells790.

According to some exemplary embodiments, each of the layers is locatedat a different depth from the external surface of the skin.

According to some exemplary embodiments, in a cellulite treatment,ultrasonic waves, for example unfocused ultrasonic waves are deliveredto the fat tissue layer, for example to affect fat cells and/orconnective tissue. Additionally or optionally, in the cellulitetreatment, the ultrasonic waves are delivered to the dermis and/orepidermis layer, for example as part of a complementary skin tighteningtreatment. In some embodiments, the ultrasonic waves are delivered tothe epidermis and/or dermis.

According to some exemplary embodiments, in a cellulite treatment,ultrasonic waves, for example unfocused ultrasonic waves, are deliveredto blood vessels 786, providing blood to the fat cells in the fat tissuelayer. In some embodiments, the ultrasonic waves are delivered to theblood vessels 786.

According to some exemplary embodiments, in a cellulite treatment,ultrasonic waves, for example unfocused ultrasonic waves are deliveredto the reserved fat layer.

According to some exemplary embodiments, in a cellulite treatment,ultrasonic waves, for example unfocused ultrasonic waves are deliveredto the muscle layer. In some embodiments, the ultrasonic waves aredelivered to the muscle layer.

Exemplary Simulations

Several simulations were performed in order to determine frequency,intensity and duration parameter values of ultrasonic energy delivery,in order to reach a temperature level in a range of 52-57° C. for a timeduration of at least 5 seconds within a selected tissue volume.

Table A below summarizes the treatment parameter values when deliveringultrasonic waves with a frequency of 2 MHz:

TABLE A Duration ~Pick Excitation Fat temp. at temp. temp. Intensityduration range range depth [W/cm{circumflex over ( )}2] [sec] [° C.][sec] [mm] 10 42 52-57 5 6.0 12 35 52-57 5 5.7 14 30 52-57 5 5.4 16 2552-57 5 5.0 20 20 52-57 5 4.7 22 18 52-57 5 4.6 24 16 52-57 5 4.5 26 1552-57 5 4.4 28 14 52-57 5 4.3 30 13 52-57 5 4.2

FIG. 8A describes a relation between intensity levels and the depth inwhich a peak in the temperature is measured.

FIG. 8B describes simulation results obtained when using a frequency of2 MHz, intensity levels of 30 w/cm² for 8 seconds. FIG. 8C describessimulation results when using the parameter values as in FIG. 8B for atime period of 13 seconds. As shown in FIG. 8C, the temperature in thelast 5 seconds of the simulation was in a range between 52-57° C.

FIG. 8D describes simulation results obtained when using a frequency of2 MHz, intensity levels of 10 w/cm² for 37 seconds. FIG. 8E describessimulation results when using the parameter values as in FIG. 8D for atime period of 42 seconds. As shown in FIG. 8E, the temperature in thelast 5 seconds of the simulation was in a range between 52-57° C.

Table B below summarizes the treatment parameter values when deliveringultrasonic waves with a frequency of 5 MHz:

TABLE B Duration ~Pick Excitation Fat temp. at temp. temp. Intensityduration range range depth [W/cm{circumflex over ( )}2] [sec] [° C.][sec] [mm] 10 18 52-57 5 3.6 12 15 52-57 5 3.4 14 13 52-57 5 3.2 16 1152-57 5 3.0

FIG. 9A describes a relation between intensity levels and the depth inwhich a peak in the temperature is measured.

FIG. 9B describes simulation results obtained when using a frequency of5 MHz, intensity levels of 16 w/cm² for 6 seconds. FIG. 9C describessimulation results when using the parameter values as in FIG. 9B for atime period of 11 seconds. As shown in FIG. 9C, the temperature in thelast 5 seconds of the simulation was in a range between 52-57° C.

FIG. 9D describes simulation results obtained when using a frequency of5 MHz, intensity levels of 10 w/cm² for 13 seconds. FIG. 9E describessimulation results when using the parameter values as in FIG. 9D for atime period of 18 seconds. As shown in FIG. 9E, the temperature in thelast 5 seconds of the simulation was in a range between 52-57° C.

Exemplary Treatment

According to some exemplary embodiments, a treatment for reducing fatand/or cellulite, which is optionally part of a body contouringtreatment, is delivered to a subject at a selected treatment region.Reference is now made to FIG. 9F, depicting a treatment process,according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a subject to undergo a bodycontouring treatment, for example a fat and/or cellulite reductiontreatment is selected at block 902. In some embodiments, the subject isselected based on one or more subject selection parameters comprisingsubject age, current clinical condition, medical history, drug regime,sensitivity of the subject to pain, high heat and/or cold levels

Experiment

An experiment was performed to test the efficacy of a fat tissuetreatment. In the experiment and in some embodiments of the invention,subjects are selected based on one or more characteristics, for exampleage, gender, current clinical condition, medical history, and/orsensitivity of the subject to heat and cold. In the experiment and insome embodiments of the invention, subjects were evaluated 1-3 months,for example 1-2 months, 1.5-2.5 months, 2-3 months or any intermediate,shorter or longer time period.

In the experiment and in some embodiments of the invention, theultrasonic waves frequency was in a range of 10-13 Mhz, for example10.5-12 MHz, 11-12 Mhz, 11.5-12.5 Mhz, 11.5 Mhz or any intermediate,smaller or larger value or range of values. In the experiment and insome embodiments of the invention, at least part of a surface of anultrasound applicator placed in contact with the skin of a subject, wascooled to a temperature in a range of −5° C. to −15° C., for example −5°C. to −10° C., −8° C. to −15° C. or any intermediate, smaller or largerrange of temperatures.

In the experiment and in some embodiments of the invention, a subjectreceived ultrasonic waves to the Chin, with an intensity levels in arange of 3-4.2 Joules. In some embodiments, 1 Joule of energy deliveredto the tissue equals 5 cm{circumflex over ( )}2. In the experiment andin some embodiments of the invention, the ultrasonic waves to the Chinwere delivered in a series of 4 pulses, 2-7 pulses, for example 2-5pulses, 4-6 pulses, 5-7 pulses, or any intermediate, smaller or largerrange of pulses or number of pulses. In the experiment and in someembodiments of the invention, a time duration of each pulse was 5seconds or in a range of 3-6 seconds, for example 3-5 seconds, 4-5.5seconds, 4-6 seconds, or any intermediate, shorter or longer timeduration.

In the experiment and in some embodiments of the invention, a subjectreceived ultrasonic waves to the neck, for example to the submentaland/or right neck with an intensity levels in a range of 3-4.2 Joules.In the experiment and in some embodiments of the invention, theultrasonic waves to the to the neck, for example to the submental and/orright neck were delivered in a series of 32 pulses, 20-40 pulses, forexample 20-35 pulses, 30-40 pulses, 25-35 pulses, or any intermediate,smaller or larger range of pulses or number of pulses. In the experimentand in some embodiments of the invention, a time duration of each pulsewas 5 seconds or in a range of 3-6 seconds, for example 3-5 seconds,4-5.5 seconds, 4-6 seconds, or any intermediate, shorter or longer timeduration.

In the experiment and in some embodiments of the invention, a subjectreceived ultrasonic waves to the neck, for example to the left neck withan intensity levels in a range of 3-4.2 Joules. In the experiment and insome embodiments of the invention, the ultrasonic waves to the to theneck, for example to the left neck were delivered in a series of 22pulses, 10-40 pulses, for example 20-35 pulses, 30-40 pulses, 25-35pulses, or any intermediate, smaller or larger range of pulses or numberof pulses. In the experiment and in some embodiments of the invention, atime duration of each pulse was 5 seconds or in a range of 3-6 seconds,for example 3-5 seconds, 4-5.5 seconds, 4-6 seconds, or anyintermediate, shorter or longer time duration. In some embodiments,fewer pulses of ultrasonic waves are delivered to the left neck comparedto the number of pulses derived to the right neck.

In the experiment and in some embodiments of the invention, images ofthe treated region are taken at an evaluation meeting or at the home ofthe subject, 2 months, 3 months, 1 week-6 months following thetreatment, for example 2 weeks, 1 month, 2 months, 3 months or anyintermediate, shorter or longer time duration following the treatment.In the experiment and in some embodiments of the invention, the imagesare analyses using an analysis software to detect changes following thetreatment. In the experiment and in some embodiments of the invention,the analysis is performed using a system of Cherry Imaging™(www(dot)cherryimaging(dot)com/).

Reference is now made to FIGS. 10A-10E depicting tissue changes in afemale subject following treatment as part of the experiment, of theChin, Right Neck, Submental regions and the Left neck. FIGS. 10B and 10Ddescribe changes in the shape and volume of tissue in the neck 3 monthsfollowing the treatment, compared to base line FIGS. 10A and 10Crespectively. Comparison of 10D to 10C using the cherry imaging systemreveals a volume reduction of about 10.76 Cubic Centimeter (CC)following the treatment, as can also be seen in FIG. 10E.

Reference is now made to FIGS. 11A-11D, depicting tissue changes in afemale subject following treatment as part of the experiment, of theRight Neck, Submental regions and the Left neck. FIGS. 11B and 11Ddescribe changes in the shape and volume of tissue in the neck, 3 monthsfollowing the treatment, compared to base line FIGS. 11A and 11Crespectively. Comparison of 11D to 11C using the cherry imaging systemreveals a volume reduction of about 8.76 CC following the treatment.

Reference is now made to FIGS. 12A-12D, depicting tissue changes in afemale subject following treatment as part of the experiment, of theRight Neck, Submental regions and the Left neck. FIGS. 12B and 12Ddescribe changes in the shape and volume of tissue in the neck, 3 monthsfollowing the treatment, compared to base line FIGS. 12A and 12Crespectively. Comparison of 12D to 12C using the cherry imaging systemreveals a volume reduction of about 22.22 CC following the treatment.

Reference is now made to FIGS. 13A-13D, depicting tissue changes in amale subject following treatment as part of the experiment, of the RightNeck, Submental regions and the Left neck. FIGS. 13B and 13D describechanges in the shape and volume of tissue in the neck, 3 monthsfollowing the treatment, compared to base line FIGS. 13A and 13Crespectively. Comparison of 13D to 13C using the cherry imaging systemreveals a volume reduction of about 26.47 CC following the treatment.

It is expected that during the life of a patent maturing from thisapplication many relevant ultrasound transducers will be developed; thescope of the term ultrasound transducer is intended to include all suchnew technologies a priori.

As used herein with reference to quantity or value, the term “about”means “within ±10% of”.

The terms “comprises”, “comprising”, “includes”, “including”, “has”,“having” and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular forms “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, embodiments of this invention may bepresented with reference to a range format. It should be understood thatthe description in range format is merely for convenience and brevityand should not be construed as an inflexible limitation on the scope ofthe invention. Accordingly, the description of a range should beconsidered to have specifically disclosed all the possible subranges aswell as individual numerical values within that range. For example,description of a range such as “from 1 to 6” should be considered tohave specifically disclosed subranges such as “from 1 to 3”, “from 1 to4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; aswell as individual numbers within that range, for example, 1, 2, 3, 4,5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example “10-15”, “10to 15”, or any pair of numbers linked by these another such rangeindication), it is meant to include any number (fractional or integral)within the indicated range limits, including the range limits, unlessthe context clearly dictates otherwise. The phrases“range/ranging/ranges between” a first indicate number and a secondindicate number and “range/ranging/ranges from” a first indicate number“to”, “up to”, “until” or “through” (or another such range-indicatingterm) a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numbers therebetween.

Unless otherwise indicated, numbers used herein and any number rangesbased thereon are approximations within the accuracy of reasonablemeasurement and rounding errors as understood by persons skilled in theart.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting. In addition, any priority document(s) of this applicationis/are hereby incorporated herein by reference in its/their entirety.

1. A system for treating fat tissue, comprising: an ultrasoundapplicator, comprising: at least one ultrasound transducer configured togenerate unfocused ultrasonic waves in a frequency range of 1-7 MHz anddirect said unfocused ultrasonic waves to a selected tissue volumecomprising fat tissue in a hypodermis tissue layer; a control unit,comprising: a control circuitry electrically connected to said at leastone ultrasound transducer, wherein said control circuitry is configuredto activate said at least one ultrasound transducer to heat saidselected tissue volume without causing damage to other tissue layersnear the selected tissue volume. 2-3. (canceled)
 4. A system accordingto claim 54, wherein said at least two ultrasound transducers arepositioned at an angle relative to each other, and wherein said angle issmaller than 180 degrees.
 5. A system according to claim 1, wherein saidcontrol circuitry is configured to signal said at least one ultrasoundtransducer to generate said unfocused ultrasonic waves with intensityand/or frequency parameter values suitable to penetrate to a depth of atleast 4 mm into said tissue volume.
 6. A system according to claim 1,wherein said control circuitry signals said at least one ultrasoundtransducer to generate said unfocused ultrasonic waves with intensityand/or parameter values suitable to heat said fat tissue to atemperature level in a range of 45-70 □ for a time period of at least 15seconds.
 7. (canceled)
 8. A system according to claim 1, wherein saidultrasound applicator comprises a housing having an inner lumen and atleast one opening through a surface of said housing.
 9. A systemaccording to claim 8, wherein an ultrasound energy emitting surface ofsaid at least one ultrasound transducer, face at least 10% of saidopening.
 10. A system according to claim 8, wherein said ultrasoundapplicator comprises a vacuum opening in said inner lumen, and whereinsaid vacuum opening is connected to a low-pressure source.
 11. A systemaccording to claim 10, wherein said control unit is configured toactivate said low-pressure source for generating low-pressure levelswithin said inner lumen of the applicator during the activation of saidat least one ultrasound transducer.
 12. A system according to claim 1,wherein said ultrasound applicator comprises at least one coolingelement attached to said at least one ultrasound transducer, whereinsaid cooling element is configured to cool a skin layer of a tissuecontacting the at least one ultrasound transducer.
 13. A systemaccording to claim 12, wherein a temperature of said cooling element isin a range of −15° C. to −5° C.
 14. A system according to claim 12,wherein said at least one cooling element comprises at least one TEC,and wherein a cold surface of said TEC is attached to a surface of eachof said at least two ultrasound transducers or to a surface of at leastone thermal conducting transducer holder attached to the at least oneultrasound transducer. 15-16. (canceled)
 17. A system according to claim1, comprising a memory, and wherein said control circuitry is configuredto activate said at least one ultrasound transducer with activationparameters stored in said memory selected not to heat tissue layersadjacent in a depth direction to said fat tissue. 18-28. (canceled) 29.A method for treating fat tissue, comprising: delivering unfocusedultrasonic waves having a frequency level in a range of 1-7 MHz from atleast one location on the skin towards a selected tissue volumecomprising fat tissue in a hypodermis tissue layer, wherein saiddelivered unfocused ultrasonic waves heat said selected tissue volumewithout causing damage to other tissue layers near said selected tissuevolume; cooling said skin during and/or prior to said delivery.
 30. Amethod according to claim 29, wherein said delivering comprisesdelivering said unfocused ultrasonic waves from at least twospaced-apart locations on the skin towards said selected tissue volume.31. A method according to claim 29, comprising: applying vacuum on saidtissue during said delivering.
 32. (canceled)
 33. A method according toclaim 29, comprising heating said fat tissue to a temperature level in arange of 45-70 □ for at least 5 seconds. 34-36. (canceled)
 37. A methodaccording to claim 30, comprising adjusting angles of said unfocusedultrasonic waves according to a location of said fat tissue.
 38. Amethod according to claim 29, comprising generating said unfocusedultrasonic waves with frequency and/or intensity values according tosaid determined depth of said fat tissue.
 39. A method according toclaim 29, wherein said generating comprises generating said unfocusedultrasonic waves with frequency and/or intensity parameter valuessufficient for penetrating into a depth of at least 4 mm into saidtissue. 40-53. (canceled)
 54. A system according to claim 1, whereinsaid at least one ultrasound transducer comprises at least twoultrasound transducers configured to generate and direct said unfocusedultrasonic waves to said selected tissue volume, wherein said unfocusedultrasonic waves generated by said two or more ultrasound transducersconverge in said selected tissue volume.